JUNE 2006
WEEK ENDING JUNE 3
PRODUCT Verelan® PM
extended-release capsules (verapamil hydrochloride), 300 mg, 100 capsules per
bottle, Rx only, NDC 0091-4087-01,
CODE Lots:
5K066 (exp. 7/07), 5K124 (exp. 8/07)
RECALLING
FIRM/MANUFACTURER Elan Holdings, Inc., Gainesville, GA
REASON Low fill weight
capsules.
VOLUME OF PRODUCT IN COMMERCE 10,269/100-capsule
bottles
DISTRIBUTION Nationwide
PRODUCT Pulmicort Respules 0.25
mg/2mL (budesonide inhalation suspension) Rx only, NDC 0186-1988-04,
CODE
Lot Number: MA0133 Exp. Date: JAN 08
RECALLING
FIRM/MANUFACTURER AstraZeneca LP, Westborough, MA
REASON Lack of assurance of
sterility.
VOLUME OF PRODUCT IN COMMERCE 384
units
DISTRIBUTION Nationwide
PRODUCT Greenstone brand
cabergoline tablets, 0.5 mg, 8 tablets per bottle, RX only, NDC 59762-0100-1,
CODE
Lot B922A (exp. 3/07), NDC
59762-0100-1
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Greenstone Ltd., Peapack, NJ,
Manufacturer: Pfizer Italia S.r.l. Marino del
Tronto, Italy.
REASON Product will not meet
established potency and impurity specifications throughout its labeled shelf
life.
VOLUME OF PRODUCT IN COMMERCE 54,270/8 tablet
bottles
DISTRIBUTION Nationwide and PR
PRODUCT Dostinex tablets (cabergoline), 0.5 mg, 8 tablets per bottle, Rx only, NDC 0013-7001-12,
CODE
Lots: A526A (exp. 2/07), A528A (exp. 2/07), B086A
(exp. 5/07), B599Y (exp. 1/07), B921Z (exp. 3/07), 4HXG7B (exp. 10/06), 4HXGAK
(exp. 11/06), 4HXG6E (exp. 10/06), 4HXG6F (exp. 10/06); NDC
0013-7001-12
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Pfizer Inc., NY, NY,
Manufacturer:
Pfizer Italia S.r.l., Marino, Italy.
REASON Product will not meet established potency and
impurity specifications throughout its labeled shelf life.
VOLUME OF
PRODUCT IN COMMERCE 404,969/8-tablet
bottles
DISTRIBUTION Nationwide and PR
PRODUCT
a) PREMPRO™ (conjugated
estrogen/medroxyprogesterone acetate tablets) 0.45
mg/1.5 mg, Rx only, NDC
0046-0937-08.
b) PREMPRO™ (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3
mg/1.5 mg, Rx only, NDC
0046-0938-08.
CODE
a) Lot A66957 (exp. 8/06);
b) Lot B13132 (exp. 2/07)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals,
Philadelphia, PA,
Manufacturer: Wyeth
Pharmaceuticals, Rouses Point, NY,
REASON FAILED USP DISSOLUTION TEST REQUIREMENT.
VOLUME OF PRODUCT IN COMMERCE
Prempro 0.45 mg/1.5 mg: 25,186
cartons of 3 dispensers;
Prempro 0.3 mg/1.5 mg: 23,254 cartons of 3
dispensers
DISTRIBUTION Nationwide
WEEK ENDING JUNE 10
PRODUCT Retavase Half-Kit (Reteplase recombinant) with 1 single-use vial Retavase powder (10 unit vial;
10.4 U strength), Rx only, NDC 67286-040-02
CODE Lot numbers: 767174E (exp. 12/06), 767174F (exp.
12/06), 767486B (exp. 3/07), 767486D (exp. 3/07);
RECALLING
FIRM/MANUFACTURER
Recalling Firm/Manufacturer: Pdl
Biopharma, Freemont, CA
Packager/Labeler: Cardinal Health Packaging Services,
Philadelphia, PA.
REASON Kit may contain unlabeled vial of drug
product.
VOLUME OF PRODUCT IN COMMERCE 5,908
half-kits
DISTRIBUTION Nationwide
WEEK ENDING JUNE 17
PRODUCT Acetaminophen 500 mg Tablets, OTC, distributed in bottles
of 100 tablets and 1000 tablets or in bulk form. (1) NDC 0677-1784-10 --- URL
brand ACETAMINOPHEN TABLETS, USP --- 500 mg --- EXTRA STRENGTH --- 1000 TABLETS
--- (2) NDC 0904-1988-80 --- MAJOR brand EXTRA STRENGTH Mapap TABLETS --- 1000
ACETAMINOPHEN TABLETS --- 500 MG. EACH --- (3) NDC 62107-050-01 --- HealthSen$e
brand TACTINAL Tablets --- Extra Strength - 500mg --- Acetaminophen --- 500 mg
each --- 100 Tablets. The product was also sold to 1 account as bulk tablets,
CODE
Lot 03M847 (exp. 12/06)
RECALLING
FIRM/MANUFACTURER PDK Labs, Inc., Hauppauge, NY,
REASON Firm
received a complaint of spotted (discolored) tablets due to mold
contamination.
VOLUME OF PRODUCT IN COMMERCE 4.5 Million
tablets
DISTRIBUTION Nationwide
WEEK ENDING JUNE 24
Novartis Consumer Health Conducts Recall of Triaminic Vapor Patch
Novartis Consumer Health announced today it is conducting a recall of all Vapor Patch product marketed under the Triaminic brand due to the serious adverse health effects that could result if the product is ingested by the child removing the patch and chewing on it.
Consumers who have Triaminic Vapor Patches should stop using them immediately.
All lots are being recalled in both product lines of mentholated cherry scent and menthol scent. Triaminic Vapor Patch contains camphor, eucalyptus oil and menthol.
Triaminic Vapor Patch is labeled as a cough suppressant for children two (2) years of age and older. The directions on the label indicate the patch is to be applied to the throat or chest to allow the vapors to reach the nose and mouth. Multiple patches can be applied. Once applied, the patch would be within close reach for a child to remove and place in his/her mouth.The Vapor Patch is a topical cough product applied externally and not for oral consumption.
The product is sold nationwide over the counter at pharmacies and retail stores.
This recall affects only the Vapor Patch. Consumers should immediately discontinue use of this product and return it to their point of purchase for a full refund or discard it.
Consumers requiring more information about this recall can contact Novartis Consumer and Professional Affairs Call Center at 1-800-452-0051 or visit www.triaminic.com.
PRODUCT
a) Thyro-Tab, 0.025 mg,
packaged in bulk 150, 000-tablet drums for repacking, Rx Only,
b) Levothroid Tablets
(levothyroxine sodium tablets, USP), 25 mcg,
packaged in 100 and 1,000 tablet bottles, Rx only --- NDC 0456-1320-01
(100's) and NDC 0456-1320-00 (1000's),
CODE
a)
HA20205, Exp. August, 2006;
b) Lot 080524, Exp. August, 2006 (100's)
and Lot 090509, Exp. August, 2006 (1,000's)
RECALLING
FIRM/MANUFACTURER Lloyd Inc. of Iowa, Shenandoah, IA,
REASON Subpotent (6-month
stability testing interval).
VOLUME OF PRODUCT IN COMMERCE
a)
1,921,835 tablets;
b) 10,110/100-tablet bottles and 870/1,000-tablet
bottles
DISTRIBUTION Nationwide
PRODUCT
a) Citrucel Fiber
Laxative Powder (methylcellulose) Fiber Therapy for Regularity, Orange
Flavor, in 16, 30, 50 and 65 oz canisters, in 0.67 oz packets and in 20
count containers,
b) Citrucel Fiber Laxative Sugar Free
Powder (methylcellulose), Orange Flavor, in 8.6, 16.9, 32, 42 oz canisters,
0.36 oz packets both individually and in
20 count containers,
CODE
All lots: Item Number, Lot Number Lot Exp Date
Citrucel Orange - 1 dose packet: 041810 02H074 09/30/06; 041810 02H075 09/30/06;
041810 03F223 06/30/07; Citrucel Reg. Powder 16 oz: 041817 02F467 06/30/06;
041817 02F468 06/30/06; 041817 02G327 07/31/06; 041817 02G328 07/31/06; 041817
02G329 07/31/06; 041817 02G330 07/31/06; 041817 02G331 07/30/06; 041817 02H294
08/30/06; 041817 02H295 08/30/06; 041817 02H296 08/30/06; 041817 02H297
08/30/06; 041817 02J063 09/30/06; 041817 02J064 09/30/06; 041817 02J065
09/30/06; 041817 02J066 09/30/06; 041817 02J185 09/30/06; 041817 02J186
10/30/06; 041817 02J187 09/30/06; 041817 02J188 09/30/06; 041817 02J324
09/30/06; 041817 02M209 11/30/06; 041817 02M210 11/30/06; 041817 02M211
11/30/06; 041817 02M212 11/30/06; 041817 02M213 11/30/06; 041817 02M214
11/30/06; 041817 02M215 11/28/06; 041817 02M216 11/28/06; 041817 02M218
11/28/06; 041817 03A504 01/31/07; 041817 03A505 01/31/07; 041817 03A506
01/31/07; 041817 03A507 01/31/07; 041817B 03E140 05/31/07; 041817B 03E143
05/31/07; 041817B 03E190 05/31/07; 041817B 03E191 05/31/07; 041817B 03E192
05/31/07; 041817B 03E318 06/30/07; 041817B 03E319 06/30/07; 041817B 03F192
06/30/07; 041817B 03F193 06/30/07; 041817B 03F194 06/30/07; 041817B 03F195
06/30/07; 041817B 03G154 07/31/07; 041817B 03G155 07/31/07; 041817B 03G156
07/31/07; 041817B 03G157 07/31/07; 041817B 03G158 07/31/07; 041817B 03G238
07/31/07; 041817B 03G239 07/31/07; 041817B 03H154 09/30/07; 041817B 03H155
09/30/07; 041817B 03H156 09/30/07; 041817B 03H157 09/30/07; 041817B 03H158
09/30/07; 041817B 03H159 09/30/07; 041817B 03H160 09/30/07; 041817B 03K141
09/30/07; 041817B 03K151 10/31/07; 041817B 03K152 11/30/07; 041817B 03K153
11/30/07; 041817B 03M129 11/30/07; 041817B 03M130 11/30/07; 041817B 04B086
02/28/08; 041817B 04D180 04/30/08; 041817B 04D181 04/30/08; 041817B 04E388
05/31/08; 041817B 04E389 05/31/08; 041817B 04E390 05/31/08; 041817B 04E391
05/31/08; 041817B 04E392 05/31/08; 041817B 04E393 05/31/08; 041817B 04E394
05/31/08; 041817B 04E395 05/31/08; 041817B 04H244 09/30/08; 041817B 04H245
09/30/08; 041817B 04K131 10/31/08; 041817B 04K132 10/31/08; 041817B 04K133
10/31/08; 041817B 04K134 10/31/08; 041817B 04K135 10/31/08; 041817B 04K136
10/31/08; 041817B 04N102 12/31/08; 041817B 04N103 12/31/08; 041817B 04N104
12/31/08; 041817B 04N105 12/31/08; 041817B 04N265 12/31/08; 041817B 05B165
03/31/09; 041817B 05C071 04/30/09; 041817B 05C072 04/30/09; 041817B 05D077
04/30/09; 041817B 05D078 04/30/09; 041817B 05D079 04/30/09; 041817B 05E050
06/30/09; 041817B 05E051 06/30/09; 041817B 05E052 06/30/09; 041817B 05F060
07/31/09; 041817B 05F061 07/31/09; 041817B 05G042 07/31/09; 041817B 05G043
06/30/09; 041817B 05H016 08/31/09; 041817B 05H017 08/31/09; 041817B 05J031
09/30/09; 041817B 05J032 09/30/09; 041817B 05J114 10/31/09; 041817B 05J115
10/31/09; 041817B 05J116 10/31/09; 041817B 05M160 11/30/09; 041817B 05M161
11/30/09; 041817B 05N057 01/31/10; 041817B 05N058 01/31/10; 041817B 3B28CA
11/30/06; 041817B 3C05C 11/30/06; 041817B 3C05CA 11/30/06; 041817B 3C05CB
11/30/06; 041817B 3C05CC 11/30/06; 041817B 3C05CD 11/30/06; Citrucel Orange Conv. Pack: 041825 03E414 06/30/07; 041825 03J294 09/30/07; 041825 03N168
12/31/07; 041825 03N169 12/31/07; 041825 03N170 12/31/07; 041825 04E327
05/31/08; 041825 04E328 05/31/08; 041825 04N076 12/31/08; 041825 05C469
04/30/09; 041825 4J05N 06/30/06; 041825 4J07N 06/30/06; 041825 4J11N 03/30/06;
041825 4J18N 03/30/06; Citrucel Reg Powder 30 oz: 041830 02E337 04/30/06; 041830
02E338 04/30/06; 041830 02E339 04/30/06; 041830 02E340 04/30/06; 041830 02E341
05/31/06; 041830 02E342 05/31/06; 041830 02E343 05/31/06; 041830 02E344
05/30/06; 041830 02E345 05/31/06; 041830 02G316 07/30/06; 041830 02G317
07/30/06; 041830 02G318 07/30/06; 041830 02G319 07/30/06; 041830 02G320
07/30/06; 041830 02G321 07/30/06; 041830 02G322 07/30/06; 041830 02G323
07/20/06; 041830 02G324 07/30/06; 041830 02G325 07/30/06; 041830 02G326
07/30/06; 041830 02H298 08/31/06; 041830 02H299 08/30/06; 041830 02H300
08/30/06; 041830 02H301 08/30/06; 041830 02H302 08/30/06; 041830 02H303
08/30/06; 041830 02H304 08/30/06; 041830 02H305 08/30/06; 041830 02H306
08/30/06; 041830 02H307 08/30/06; 041830 02H308 08/30/06; 041830 02K032
10/30/06; 041830 02K033 10/30/06; 041830 02K034 10/30/06; 041830 02K035
10/30/06; 041830 02K036 10/30/06; 041830 02K501 10/30/06; 041830 02K502
10/30/06; 041830 02K503 10/30/06; 041830 02K504 10/30/06; 041830 02K505
10/30/06; 041830 02M220 11/28/06; 041830 02M223 11/28/06; 041830 02M377
11/28/06; 041830 02N341 01/31/07; 041830 02N342 01/31/07; 041830 02N343
01/31/07; 041830 02N344 01/31/07; 041830 02N345 01/31/07; 041830 03A495
01/31/07; 041830 03A496 01/31/07; 041830 03A497 01/31/07; 041830 03A498
01/31/07; 041830 03A499 01/31/07; 041830 3B28N 05/31/06; 041830 3C03N 05/31/06;
041830 3C03N1 05/31/06; 041830 3C04N 05/31/06; 041830 3E21N 05/31/06; 041830B
03E184 05/31/07; 041830B 03E185 05/31/07; 041830B 03E186 05/31/07; 041830B
03E187 05/31/07; 041830B 03E188 05/31/07; 041830B 03E189 05/31/07; 041830B
03E306 06/30/07; 041830B 03E307 06/30/07; 041830B 03E308 06/30/07; 041830B
03E309 06/30/07; 041830B 03E310 06/30/07; 041830B 03E311 06/30/07; 041830B
03E312 06/30/07; 041830B 03E313 06/30/07; 041830B 03E314 06/30/07; 041830B
03E315 06/30/07; 041830B 03E316 06/30/07; 041830B 03E317 06/30/07; 041830B
03G148 06/30/07; 041830B 03G149 06/30/07; 041830B 03G150 07/31/07; 041830B
03G151 07/31/07; 041830B 03G152 07/31/07; 041830B 03G153 07/31/07; 041830B
03H161 09/30/07; 041830B 03H162 09/30/07; 041830B 03H165 09/30/07; 041830B
03K146 10/31/07; 041830B 03K147 10/31/07; 041830B 03K148 10/31/07; 041830B
03K149 10/31/07; 041830B 03K150 10/31/07; 041830B 03M125 11/30/07; 041830B
03M126 11/30/07; 041830B 03N253 11/30/07; 041830B 03N254 12/31/07; 041830B
03N255 12/31/07; 041830B 03N256 12/31/07; 041830B 04B087 02/28/08; 041830B
04B088 02/28/08; 041830B 04B089 02/28/08; 041830B 04B090 02/28/08; 041830B
04D185 04/30/08; 041830B 04D186 04/30/08; 041830B 04D187 04/30/08; 041830B
04D188 04/30/08; 041830B 04D189 04/30/08; 041830B 04F244 05/31/08; 041830B
04F245 05/31/08; 041830B 04F246 05/31/08; 041830B 04F247 06/30/08; 041830B
04F248 06/30/08; 041830B 04F249 06/30/08; 041830B 04F250 06/30/08; 041830B
04F251 06/30/08; 041830B 04F252 06/30/08; 041830B 04F253 06/30/08; 041830B
04F254 06/30/08; 041830B 04F255 06/30/08; 041830B 04F256 06/30/08; 041830B
04F257 06/30/08; 041830B 04F258 06/30/08; 041830B 04H237 09/30/08; 041830B
04H238 09/30/08; 041830B 04H239 09/30/08; 041830B 04H240 09/30/08; 041830B
04H241 09/30/08; 041830B 04H242 09/30/08; 041830B 04H243 09/30/08; 041830B
04K124 10/31/08; 041830B 04K125 10/31/08; 041830B 04K126 10/31/08; 041830B
04K127 10/31/08; 041830B 04K128 10/31/08; 041830B 04K129 10/31/08; 041830B
04K130 10/31/08; 041830B 04N108 12/31/08; 041830B 04N109 12/31/08; 041830B
04N110 12/31/08; 041830B 04N111 12/31/08; 041830B 04N112 12/31/08; 041830B
04N113 12/31/08; 041830B 04N266 12/31/08; 041830B 05B160 03/31/09; 041830B
05B161 03/31/09; 041830B 05B162 03/31/09; 041830B 05B163 03/31/09; 041830B
05B164 03/31/09; 041830B 05D067 04/30/09; 041830B 05D068 04/30/09; 041830B
05D069 04/30/09; 041830B 05D070 04/30/09; 041830B 05D071 04/30/09; 041830B
05D072 04/30/09; 041830B 05D073 04/30/09; 041830B 05D074 04/30/09; 041830B
05D075 04/30/09; 041830B 05D076 04/30/09; 041830B 05E047 06/30/09; 041830B
05E048 06/30/09; 041830B 05E049 06/30/09; 041830B 05E067 06/30/09; 041830B
05E068 06/30/09; 041830B 05E069 06/30/09; 041830B 05F055 07/31/09; 041830B
05F056 07/31/09; 041830B 05F057 07/31/09; 041830B 05F058 07/31/09; 041830B
05F059 07/31/09; 041830B 05G038 07/31/09; 041830B 05G039 07/31/09; 041830B
05G040 07/31/09; 041830B 05G041 07/31/09; 041830B 05G137 07/31/09; 041830B
05H075 09/30/09; 041830B 05H076 09/30/09; 041830B 05H077 09/30/09; 041830B
05H078 09/30/09; 041830B 05H079 09/30/09; 041830B 05H080 09/30/09; 041830B
05H081 09/30/09; 041830B 05H082 09/30/09; 041830B 05K045 04/30/09; 041830B
05K046 10/31/09; 041830B 05K047 10/31/09; 041830B 05K048 10/31/09; 041830B
05K049 10/31/09; 041830B 05K050 10/31/09; 041830B 05K273 10/31/09; 041830B
05K274 10/31/09; 041830B 05M061 11/30/09; 041830B 05M062 11/30/09; 041830B
05M063 12/31/09; 041830B 05N059 01/31/10; 041830B 05N060 01/31/10; 041830B
05N061 01/31/10; 041830B 05N062 01/31/10; 041830B 3B26C 10/31/06; 041830B 3B26CA
10/31/06; 041830B 3C05C 11/28/06; 041830B 3C05CA 11/28/06; 041830B 3E05N
01/31/07; 041830B 3H05N 05/31/06; 041830B 3K11N 05/31/06; 041830B 3K14N
05/31/06; 041830B 4H09N 09/30/07; 041830B 4H09N1 07/31/07; 041830B 4H10N
07/31/07; 041830B 4H12N 07/31/07; 041830B 4L03N 09/30/07; 041830B 4L03N1
09/30/07; 041830B 4L06N 09/30/07; 041830B 4L09N 09/30/07; Citrucel Orange with
free 6 ct. caplet sample: 041833 2E07N 02/28/04; 041833 2E08N 02/28/04; 041833
2E09N 02/28/04; 041833 2E09N1 02/28/04; 041833 2F13N 02/28/04; 041833 2L11N
02/28/04; 041833 2L11N1 06/30/04; 041833 2L12N 06/30/04; 041833 2L12N1 06/30/04;
041833 2L13N 06/30/04; 041833 2L13N1 06/30/04; Citrucel Orange with free
Pedometer: 041834 3E30N 11/30/06; 041834 3F04N 11/28/06; 041834 3F04N1 11/28/06;
041834 3F05N 01/31/07; 041834 3F06N 01/31/07; 041834 3F06N1 01/31/07; 041834
3F09N 01/31/07; 041834 3F10N 01/31/07; 041834 3F10N1 01/31/07; 041834 3F10N2
01/31/07; 041834 3F11N 01/31/07; 041834 3F11N1 01/31/07; 041834 3F11N2 01/31/07;
041834 3F12N 01/31/07; 041834 3F12N1 01/31/07; 041834 3F12N2 01/31/07; 041834
3F13N 01/31/07; 041834 3F24N 01/31/07; 041834 3F24N1 01/31/07; 041834 3F25N
01/31/07; 041834 3F27N 01/31/07; 041850 02F469 06/30/06; Citrucel Reg Powder 65
oz: 041850 02F470 06/30/06; 041850 02F471 06/30/06; 041850 02F472 06/30/06;
041850 02H315 09/30/06; 041850 02H316 09/30/06; 041850 02H317 09/30/06; 041850
02H318 09/30/06; 041850 02M205 11/30/06; 041850 02M206 11/30/06; 041850 02M207
11/30/06; 041850 02M208 11/30/06; 041850 02N337 01/31/07; 041850 02N338
01/31/07; 041850 02N339 01/31/07; 041850 02N340 01/31/07; 041850 03A508
01/31/07; 041850 03A509 01/31/07; 041850 03A510 01/31/07; 041850 03A511
01/31/07; 041850 03B246 02/28/07; 041850 03B247 02/28/07; 041850 03B248
02/28/07; 041850 03B249 02/28/07; 041850 03E305 06/30/07; 041850 03G146
06/30/07; 041850 03G147 06/30/07; 041850 03H166 09/30/07; 041850 03M124
11/30/07; 041850 03N257 12/31/07; 041850 04B091 02/28/08; 041850 04B092
02/28/08; 041850 04B093 02/28/08; 041850 04D190 04/30/08; 041850 04D191
04/30/08; 041850 04D192 04/30/08; 041850 04D193 04/30/08; 041850 04D194
04/30/08; 041850 04E386 05/31/08; 041850 04E387 05/31/08; 041850 04H235
09/30/08; 041850 04H236 09/30/08; 041850 04K122 10/31/08; 041850 04K123
10/31/08; 041850 04N106 12/31/08; 041850 04N107 12/31/08; 041850 05B159
03/31/09; 041850 05C067 04/30/09; 041850 05C068 04/30/09; 041850 05C069
04/30/09; 041850 05C070 04/30/09; 041850 05E045 06/30/09; 041850 05E046
06/30/09; 041850 05F053 07/31/09; 041850 05F054 07/31/09; 041850 05H013
08/31/09; 041850 05H014 08/31/09; 041850 05H015 08/31/09; 041850 05J033
09/30/09; 041850 05J034 09/30/09; 041850 05J279 09/30/09; 041850 05M059
12/31/09; 041850 05M060 12/31/09; 041850 05M158 12/31/09; 041850 05M159
12/31/09; 041850 3B26N 08/23/04; 041850 3B26N1 08/23/04; 041850 3B26N2 11/30/04;
041850 3B27N 12/31/04; 041850 3B27N1 02/28/05; 041850 3B27N2 02/28/05; 041850
3B27N3 02/28/05; 041850 3B28N 02/28/05; 041850 3B28N1 02/28/05; 041850 3B28N2
02/28/05; 041850 3B28N3 02/28/05; 041850 3B28N4 02/28/05; 041850 3B28N5
06/30/05; 041850 3C03N 08/31/05; 041850 3C24N 08/30/05; 041850 3C28N 05/31/05;
041850 3C28N1 06/30/05; 041850 3C28N2 10/31/05; 041850 3C28N3 10/31/05; 041850
3C28N4 10/31/05; 041850 3E20N 10/31/05; 041850 3E20N1 10/31/05; 041850 3E20N2
10/31/05; 041850 3E20N3 06/30/06; 041850 3E20N4 01/31/06; 041850 3H06N 01/31/06;
041850 3H06N1 06/30/06; Citrucel Powder/Caplets: 042016 2E08N 03/31/04; 042016
2E29N 04/30/04; 042016 2F05N 04/30/04; 042016 2G12N 05/31/04; 042016 2H02N
05/31/04; 042016 2H16N 05/31/04; 042016 2H19N 06/30/04; Citrucel Mixed PDQ
Display: 042060 2I16N 06/30/04; 042060 2I18N 06/30/04; 042060 2J07N 08/30/04;
042060 2J09N 08/30/04; 042060 2J10N 08/31/04; 042060 2L03N 10/30/04; 042060
2L04N 10/30/04; 042060 3A28N 09/30/04; 042060 3A28N1 10/31/04; 042060 3B28N
05/31/04; 042060 3C03N 05/31/04; 042060 3C03N1 05/31/04; 042060 3C04N 06/30/04;
042060 3E21N 06/30/04; 042060 3E27N 12/31/04; 042060A 2K11N 03/30/03; 042060A
2K13N 03/30/03; 042060A 2K15N 03/30/03; Citrucel Mixed display Take the
Challenge: 042065 3J30N 09/30/04; Citrucel 18 pc Speedpk: 042080 5E09W 02/28/07;
042080 5E12N 02/28/07; Citrucel Mixed Pallet: 042140 2K13N 08/30/05; 042140
2L09W 10/30/05; 042140 3K17N 06/30/06; 042140 3K24N 08/31/06; 042140 3K24W
10/31/06; 042140 3L08W 09/30/06; 042140 3L15W 10/31/06; 042140A 4E25N 01/31/07;
042140A 4E26N 01/31/07; 042140A 4K16N 09/30/07; 042140A 4L06N 11/30/07; 042140A
4L07N 11/30/07; 042140A 4L08N 10/31/07; Citrucel Powder Mix Pallet: 042144 5L09N
09/30/09; 042144 5L10N 06/30/09; 042144 5L12N 09/30/09; Citrucel Sidekick:
042145 2K21N 03/30/03; 042145 2K26N 03/30/03; 042145 3A30N 03/30/03; 042145
3K12N 09/30/04; 042145 3K12N1 09/30/04; 042145 3K26N 09/30/04; 042145 3L02N
09/30/04; 042145 3L04N 09/30/04; Citrucel Mix 18pc End Cap: 044350 5K28N
03/31/08; 044350 5K29N 03/31/08; 044350 5K29N1 03/31/08; 044350 5K30N 03/31/08;
044350 5K30N1 03/31/08; 044350 5K30N2 03/31/08; 044350 5L01N 03/31/08; 044350
5L01N1 03/31/08; 044350 5L08N 03/31/08; Citrucel Reg. Powder 65 oz: 284588
02F459 06/30/06; 284588 02F460 06/30/06; 284588 02F461 06/30/06; 284588 02F462
06/30/06; 284588 02F463 06/30/06; 284588 02F464 06/30/06; 284588 02F465
06/30/06; 284588 02F466 06/30/06; 284588 02H309 09/30/06; 284588 02H310
09/30/06; 284588 02H311 09/30/06; 284588 02H312 09/30/06; 284588 02K037
11/30/06; 284588 02K038 11/30/06; 284588 02K039 11/30/06; 284588 02K040
11/30/06; 284588 03M122 11/30/07; 284588 03M123 11/30/07; 284588 04D182
04/30/08; 284588 04D183 04/30/08; 284588 04D184 04/30/08; 284588 04E384
05/31/08; 284588 04E385 05/31/08; 284588 04H234 09/30/08; 284588 04K138
06/30/08; 284588 04N099 10/31/08; 284588 04N100 10/31/08; 284588 04N101
12/31/08; 284588 05C065 04/30/09; 284588 05C066 04/30/09; 284588 05C189
04/30/09; 284588 05C190 04/30/09; 284588 05F049 06/30/09; 284588 05F050
06/30/09; 284588 05F051 06/30/09; 284588 05F052 07/31/09; 284588 05K042
10/31/09; 284588 05N140 12/31/09; 284588 05N141 12/31/09; 284588 06A064
01/31/10; 284588 06A065 01/31/10; 284588A 03E134 05/31/07; 284588A 03E196
05/31/07; 284588A 03E197 05/31/07; 284588A 03E198 05/31/07; 284588A 03F196
06/30/07; 284588A 03K142 10/31/07; 284588A 03K143 10/31/07; 284588A 03K144
10/31/07; 284588A 03K145 10/31/07; 284588A 03M122 11/30/07; 284588A 03M123
11/30/07; 284588A 03N313 10/31/07; 284588A 03N314 10/31/07; 284588A 04B094
02/28/08; 284588A 3K11N 06/30/06; 284588A 3K12N 06/30/06; 284588A 3K12N1
09/30/06; 284588A 3K12N3 09/30/06; 284588A 3K12N4 11/30/06; 284588A 3K13N
11/30/06; Citrucel Orange 65 oz with free Pedometer: 287596 3G08N 03/31/06;
287596 3G09N 06/30/06; 287596 3G10N 11/30/06; 287596 3G11N 11/30/06; 287596
3G11N1 11/30/06; 287596 3G14N 06/30/06;
b) All lots: Citrucel Sugar Free
Powder, 8.6 oz: 042009B 03D269 06/30/06; 042009B 03D270 06/30/06; 042009B 03E268
06/30/06; 042009B 03E410 06/30/06; 042009B 03G159 08/31/06; 042009B 03H152
09/30/06; 042009B 03H153 09/30/06; 042009B 03K161 10/31/06; 042009B 03N267
02/28/07; 042009B 03N268 02/28/07; 042009B 04C041 02/28/07; 042009B 04C041A
02/28/07; 042009B 04G234 07/31/07; 042009B 04G235 07/31/07; 042009B 04G236
07/31/07; 042009B 04G237 07/31/07; 042009B 04K139 11/30/07; 042009B 04K140
11/30/07; 042009B 04K395 11/30/07; 042009B 04N117 11/30/07; 042009B 04N118
12/31/07; 042009B 04N319 11/30/07; 042009B 05A286 12/31/07; 042009B 05C045
03/31/08; 042009B 05D100 05/31/08; 042009B 05D101 05/31/08; 042009B 05G044
07/31/09; 042009B 05G045 07/31/09; 042009B 05J044 10/30/09; 042009B 05J113
08/31/09; 042009B 05K040 10/31/09; 042009B 05M156 01/31/10; 042009B 05M157
01/31/10; Citrucel Sugar Free Powder 16.9 oz: 042017B 03D263 05/31/06; 042017B
03D264 05/31/06; 042017B 03D265 05/31/06; 042017B 03D266 05/31/06; 042017B
03D267 05/31/06; 042017B 03D268 05/31/06; 042017B 03E269 06/30/06; 042017B
03E270 06/30/06; 042017B 03E271 06/30/06; 042017B 03F186 06/30/06; 042017B
03F187 06/30/06; 042017B 03F188 06/30/06; 042017B 03F189 06/30/06; 042017B
03F190 06/30/06; 042017B 03F191 06/30/06; 042017B 03G160 08/31/06; 042017B
03G161 08/31/06; 042017B 03G162 08/31/06; 042017B 03G163 08/31/06; 042017B
03H149 08/31/06; 042017B 03H150 08/31/06; 042017B 03H151 08/31/06; 042017B
03K124 10/31/06; 042017B 03K136 10/31/06; 042017B 03K137 10/31/06; 042017B
03K138 10/31/06; 042017B 03K139 10/31/06; 042017B 03K140 10/31/06; 042017B
03M065 11/30/06; 042017B 03M110 11/30/06; 042017B 03M111 11/30/06; 042017B
03M112 11/30/06; 042017B 03M113 11/30/06; 042017B 03M114 01/31/07; 042017B
03M115 01/31/07; 042017B 03M116 01/31/07; 042017B 03M117 01/31/07; 042017B
04A287 01/31/07; 042017B 04A288 01/31/07; 042017B 04A289 01/31/07; 042017B
04A290 01/31/07; 042017B 04C039 02/28/07; 042017B 04C040 02/28/07; 042017B
04E259 06/30/07; 042017B 04E260 06/30/07; 042017B 04E261 06/30/07; 042017B
04E262 05/31/07; 042017B 04E263 05/31/07; 042017B 04E264 05/31/07; 042017B
04E265 05/31/07; 042017B 04E266 05/31/07; 042017B 04E267 05/30/07; 042017B
04E268 05/30/07; 042017B 04G142 05/31/07; 042017B 04G143 05/31/07; 042017B
04G144 05/31/07; 042017B 04G145 06/30/07; 042017B 04G146 06/30/07; 042017B
04G147 06/30/07; 042017B 04G148 06/30/07; 042017B 04G149 06/30/07; 042017B
04G407 02/28/07; 042017B 04G408 02/28/07; 042017B 04H229 07/31/07; 042017B
04H230 07/31/07; 042017B 04H231 08/31/07; 042017B 04H232 08/31/07; 042017B
04J355 09/30/07; 042017B 04J356 09/30/07; 042017B 04J357 09/30/07; 042017B
04J358 09/30/07; 042017B 04K141 11/30/07; 042017B 04K142 11/30/07; 042017B
04K143 11/30/07; 042017B 04K144 11/30/07; 042017B 04K145 11/30/07; 042017B
04K146 11/30/07; 042017B 04M186 11/30/07; 042017B 04M187 11/30/07; 042017B
04M188 11/30/07; 042017B 04M189 11/30/07; 042017B 04M190 11/30/07; 042017B
04N114 12/31/07; 042017B 04N115 12/31/07; 042017B 04N116 12/31/07; 042017B
05A285 12/31/07; 042017B 05C046 03/31/08; 042017B 05C047 03/31/08; 042017B
05C048 03/31/08; 042017B 05C049 03/31/08; 042017B 05C050 03/31/08; 042017B
05C051 03/31/08; 042017B 05D084 03/31/08; 042017B 05D085 03/31/08; 042017B
05D086 05/31/08; 042017B 05D087 05/31/08; 042017B 05D088 05/31/08; 042017B
05D089 05/31/08; 042017B 05E053 06/30/08; 042017B 05E054 06/30/08; 042017B
05E055 06/30/08; 042017B 05E056 06/30/08; 042017B 05E099 06/30/08; 042017B
05E100 06/30/08; 042017B 05E101 06/30/08; 042017B 05E102 06/30/08; 042017B
05G046 07/31/09; 042017B 05G047 07/31/09; 042017B 05G089 07/31/09; 042017B
05G090 07/31/09; 042017B 05G091 07/31/09; 042017B 05G092 07/31/09; 042017B
05H024 08/31/09; 042017B 05H025 08/31/09; 042017B 05H026 08/31/09; 042017B
05J040 10/31/09; 042017B 05J041 10/31/09; 042017B 05J042 10/31/09; 042017B
05J043 10/31/09; 042017B 05M047 10/31/09; 042017B 05M048 10/31/09; 042017B
05M049 10/31/09; 042017B 05M050 10/31/09; 042017B 05M051 10/31/09; 042017B
05M052 10/31/09; 042017B 05M053 10/31/09; 042017B 05M054 10/31/09; 042017B
05M149 10/31/09; 042017B 05M150 11/30/09; 042017B 05N054 01/31/10; 042017B
05N055 01/31/10; 042017B 05N056 01/31/10; 042017B 06A072 01/31/10; 042017B 3E01N
11/30/05; 042017B 3H05N 05/31/05; 042017B 3K12N 05/31/05; 042017B 3K13N
05/31/05; 042017B 4J06N 08/31/06; 042017B 4J06N1 08/31/06; 042017B 4J07N
08/31/06; 042017B 4J07N1 10/31/06; 042017B 4J08N 10/31/06; 042017B 4J10N
10/31/06; 042017B 4L03N 08/31/06; 042017B 4L06N 08/31/06; 042017B 4L06N1
08/31/06; Citrucel Sugar Free with Free Pedometer: 042021 3F24N1 05/31/06;
042021 3F25N 05/31/06; 042021 3F26N 05/31/06; 042021 3F26N1 08/31/05; 042021
3G16N 05/31/06; 042021 3G16N1 05/31/06; 042021 3G18N 05/31/06; 042021 3G18N1
06/30/06; 042021 3G18N2 06/30/06; 042021 3G21N 06/30/06; Citrucel Sugar Free
Orange Conv. Pack: 042025 03D257 05/31/06; 042025 03D258 05/31/06; 042025 03J244
09/30/06; 042025 03J245 09/30/06; 042025 03K163 10/31/06; 042025 03K164
10/31/06; 042025 03K165 10/31/06; 042025 03K166 10/31/06; 042025 03K167
10/31/06; 042025 03N315 01/31/07; 042025 03N316 01/31/07; 042025 04B254
02/28/07; 042025 04B255 02/28/07; 042025 04B256 02/28/07; 042025 04B257
02/28/07; 042025 04E139 05/31/07; 042025 04E140 05/31/07; 042025 04E141
05/31/07; 042025 04G026 08/31/07; 042025 04G027 08/31/07; 042025 04N097
12/31/07; 042025 04N098 01/31/08; 042025 04N124 01/31/08; 042025 04N125
01/31/08; 042025 04N126 01/31/08; 042025 04N263 01/31/08; 042025 05C153
03/31/08; 042025 5B02N 09/30/07; Citrucel Sugar Free Orange - 1 dose packet:
042040 04B258 02/28/07; 042040 04E137 05/31/07; 042040 04E138 05/31/07; 042040
04H367 09/30/07; 042040 04H368 09/30/07; 042040 04N264 01/31/08; 042040 05C152
03/31/08; Citrucel Sugar Free Powder, 32 oz: 042050 03D261 05/31/06; 042050
03D262 05/31/06; 042050 03E229 06/30/06; 042050 03G164 08/31/06; 042050 03G165
08/31/06; 042050 03G166 08/31/06; 042050 03G167 08/31/06; 042050 03H146
08/31/06; 042050 03H147 08/31/06; 042050 03H148 08/31/06; 042050 03K125
10/31/06; 042050 03K126 10/31/06; 042050 03K127 10/31/06; 042050 03K128
10/31/06; 042050 03K129 10/31/06; 042050 03K154 10/31/06; 042050 03K155
10/31/06; 042050 03M105 11/30/06; 042050 03M106 11/30/06; 042050 03M107
11/30/06; 042050 03M108 11/30/06; 042050 03M109 11/30/06; 042050 04A299
02/28/07; 042050 04A300 02/28/07; 042050 04C036 02/28/07; 042050 04C037
02/28/07; 042050 04C038 02/28/07; 042050 04E254 11/30/06; 042050 04E255
11/30/06; 042050 04E256 11/30/06; 042050 04E257 11/30/06; 042050 04E258
05/31/07; 042050 04G135 07/31/07; 042050 04G136 07/31/07; 042050 04G137
07/31/07; 042050 04G138 07/31/07; 042050 04G233 07/31/07; 042050 04H222
08/31/07; 042050 04H223 08/31/07; 042050 04H224 08/31/07; 042050 04H225
08/31/07; 042050 04H226 08/31/07; 042050 04H227 09/30/07; 042050 04H228
09/30/07; 042050 04J348 09/30/07; 042050 04J349 09/30/07; 042050 04J350
09/30/07; 042050 04J351 09/30/07; 042050 04J352 09/30/07; 042050 04J353
09/30/07; 042050 04J354 09/30/07; 042050 04M011 11/30/07; 042050 04M012
11/30/07; 042050 04M013 11/30/07; 042050 04M014 11/30/07; 042050 04M015
11/30/07; 042050 04M016 11/30/07; 042050 04M017 11/30/07; 042050 04M018
11/30/07; 042050 04M019 11/30/07; 042050 04N120 12/31/07; 042050 04N267
12/31/07; 042050 05C052 03/31/08; 042050 05C053 03/31/08; 042050 05C054
03/31/08; 042050 05C055 03/31/08; 042050 05C056 03/31/08; 042050 05C057
03/31/08; 042050 05C058 03/31/08; 042050 05D097 05/31/08; 042050 05D098
05/31/08; 042050 05D099 05/31/08; 042050 05E057 06/30/08; 042050 05E058
06/30/08; 042050 05E059 06/30/08; 042050 05E060 06/30/08; 042050 05E103
06/30/08; 042050 05E104 06/30/08; 042050 05G048 07/31/09; 042050 05G049
07/31/09; 042050 05G050 07/31/09; 042050 05H021 08/31/09; 042050 05H022
08/31/09; 042050 05H023 08/31/09; 042050 05H341 07/31/09; 042050 05J037
09/30/09; 042050 05J038 09/30/09; 042050 05J039 09/30/09; 042050 05K036
09/30/09; 042050 05K037 09/30/09; 042050 05K038 09/30/09; 042050 05K039
09/30/09; 042050 05M055 11/30/09; 042050 05M056 11/30/09; 042050 05M057
11/30/09; 042050 05M058 11/30/09; 042050 05N051 08/31/09; 042050 05N052
08/31/09; 042050 05N053 10/31/09; 042050 06A069 01/31/10; 042050 06A071
01/31/10; 042050 3C26N 04/30/04; 042050 3C26N1 04/30/04; 042050 3C26N2 07/30/04;
042050 3C26N3 07/30/04; 042050 3C26N4 07/31/04; Citrucel Sugar Free Powder, 42
oz: 287589 03D259 05/31/06; 287589 03M119 11/30/06; 287589 03M120 11/30/06;
287589 03M121 11/30/06; 287589 04E244 05/31/07; 287589 04E245 05/31/07; 287589
04E246 05/31/07; 287589 04E247 05/31/07; 287589 04E248 05/31/07; 287589 04E249
05/31/07; 287589 04E250 05/31/07; 287589 04E251 05/31/07; 287589 04E252
05/31/07; 287589 04E253 05/31/07; 287589 04G127 07/31/07; 287589 04G128
07/31/07; 287589 04G129 07/31/07; 287589 04G130 07/31/07; 287589 04H218
08/31/07; 287589 04H219 08/31/07; 287589 04H220 08/31/07; 287589 04H221
08/31/07; 287589 04H534 09/30/07; 287589 04H535 09/30/07; 287589 04J346
09/30/07; 287589 04J347 09/30/07; 287589 04K257 10/31/07; 287589 04K258
10/31/07; 287589 04K259 10/31/07; 287589 04K260 11/30/07; 287589 04K261
10/31/07; 287589 04K262 11/30/07; 287589 04N121 12/31/07; 287589 04N122
12/31/07; 287589 04N123 12/31/07; 287589 04N288 09/30/07; 287589 05C059
01/31/08; 287589 05C060 03/31/08; 287589 05C061 03/31/08; 287589 05C062
03/31/08; 287589 05C063 03/31/08; 287589 05C064 03/31/08; 287589 05C185
03/31/08; 287589 05C186 03/31/08; 287589 05C187 03/31/08; 287589 05C188
03/20/08; 287589 05D090 05/31/08; 287589 05D091 05/31/08; 287589 05D092
05/31/08; 287589 05D093 05/31/08; 287589 05D094 05/31/08; 287589 05D095
05/31/08; 287589 05D096 05/31/08; 287589 05E061 06/30/08; 287589 05E062
06/30/08; 287589 05E063 06/30/09; 287589 05E064 06/30/09; 287589 05E105
06/30/09; 287589 05G051 07/31/09; 287589 05G052 07/31/09; 287589 05G053
07/31/09; 287589 05G054 07/31/09; 287589 05G055 07/31/09; 287589 05G056
07/31/09; 287589 05J035 09/30/09; 287589 05J083 09/30/09; 287589 05J085
09/30/09; 287589 05J086 09/30/09; 287589 05J087 09/30/09; 287589 05M151
11/30/09; 287589 05M152 11/30/09; 287589 05M153 11/30/09; 287589 05M154
12/31/09; 287589 05M155 12/31/09; 287589 05N142 12/31/09; 287589 05N193
12/31/09; 287589 05N194 12/31/09; 287589 06A066 11/30/09; 287589 06A067
11/30/09; 287589 06A068 12/31/09; 287589 06A351 01/31/10; 287589 4D26W 01/31/07;
287589 4D27W 01/31/07; 287589A 03E223 05/31/06; 287589A 03E224 05/31/06; 287589A
03E225 06/30/06; 287589A 03E226 06/30/06; 287589A 03E227 06/30/06; 287589A
03E411 06/30/06; 287589A 03H276 08/31/06; 287589A 03H277 08/31/06; 287589A
03H278 08/31/06; 287589A 03H279 08/31/06; 287589A 03K130 10/31/06; 287589A
03K131 10/31/06; 287589A 03K132 10/31/06; 287589A 03K133 10/31/06; 287589A
03K134 10/31/06; 287589A 03K135 10/31/06; 287589A 03M103 10/30/06; 287589A
03M104 10/31/06; 287589A 03M118 11/30/06; 287589A 03M119 11/30/06; 287589A
04A291 01/31/07; 287589A 04A292 01/31/07; 287589A 04A293 01/31/07; 287589A
04A294 01/31/07; 287589A 04A295 01/31/07; 287589A 04A296 01/31/07; 287589A
04A297 01/31/07; 287589A 04A298 01/31/07; 287589A 04C035 02/28/07; Citrucel
Sugar Free 42 oz with Pedometer: 287595 3G09N 02/28/06; 287595 3G09N1 05/31/06;
287595 3G10N 05/31/06; 287595 3G11N 05/31/06; 287595 3G11N1 06/30/05; 287595
3H14N 06/30/05; 287595 3H15N 06/30/06; 287595 3H20N 05/31/06; 287595 3H29N
05/31/06; 287595 3H29N1 05/31/06; 287595 3H29N2 06/30/06; 287595 3I02N 06/30/06;
287595 3I02N1 06/30/06
RECALLING FIRM/MANUFACTURER
Recalling
Firm: GlaxoSmithKline Consumer Healthcare, Parsippany, NJ,
Manufacturer:
ICL Performance Products LP,
St. Louis, MO.
REASON Presence of
foreign substances; small, semi-flexible metal wire detected.
VOLUME OF
PRODUCT IN COMMERCE 10,296,304 canisters/2,786,105
pouches
DISTRIBUTION Nationwide
PRODUCT Nicotine Polarcrilex Gum,
4 mg (nicotine), original flavor, OTC, packaged in blister strip packages of 110
or 170 pieces per package under the Walmart Equate (NDC 49035-170-25) and the
Major Nicorelief (NDC 0904-5735-11) brand names,
CODE Lot numbers: 6CE0606 and 6CE0810
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Perrigo Company, Allegan, MI,
Manufacturer: Fertin Pharma A/S,
Allegan, MI.
REASON Mislabeling: Some of the
foil packs inside the carton are mislabeled with as 2 mg., when the strength is
actually 4 mg.
VOLUME OF PRODUCT IN COMMERCE 2,448
packages
DISTRIBUTION Nationwide
PRODUCT Potassium PHOSphate 15
mMol in 0.9% Sodium Chloride, 250mL, Flexible Plastic Bag. For Intravenous Use.
Product Order Number: Q3045,
CODE Lot number:
MP002445, Exp. 5/1/2006
RECALLING FIRM/MANUFACTURER Solunet LLC,
Totowa, NJ,
REASON Mislabeled; product label inadvertently placed on
flexible plastic bag labeled as containing 5% Dextrose.
VOLUME OF PRODUCT
IN COMMERCE 50 bags
DISTRIBUTION CT
PRODUCT Acetaminophen Caplets, 650 mg, OTC, 50 caplets, packaged under the following brand names: Para-X-Dolor, Tyle-Dolor, Dolofin Forte, Pain-Eze + and Calma Dolor (Extra Fuerte),
CODE Lot 053084, Exp. 11/08; A6550, Exp.
110805
RECALLING FIRM/MANUFACTURER
Recalling Firm: Reese
Pharmaceutical Co., Cleveland, OH,
Manufacturer: Contract Pharmacal Corp., Hauppauge, NY.
REASON
Mislabeling: The product
contains an incorrect expiration date of 11/08. The correct expiration date is
1/08.
VOLUME OF PRODUCT IN COMMERCE 620/50 caplet
bottles
DISTRIBUTION Nationwide
PRODUCT Ketoprofen extended-release capsules, light turquoise blue
capsule, light turquoise blue body, imprinted with "Andrx 520" and "200 mg". Rx
only,
CODE Lot Numbers: 520E017B, 520E018A,
F520F0840A, F520F1030A, F520F1031A and F520F0368A
RECALLING
FIRM/MANUFACTURER Andrx Pharmaceuticals, Inc, Davie, FL,
REASON
CGMP
Deviations: Andrx mis-identified the manufacture of these lots as validation,
when they were study lots. The manufactured lots deviated from the master batch
record instructions.
VOLUME OF PRODUCT IN COMMERCE 3,245,400
tablets
DISTRIBUTION Nationwide
PRODUCT
a)
Westcort®
(hydrocortisone valerate) Cream, 0.2%, in 15 gram, 45 gram, & 60 gram
tubes, Rx only.
Product labeled as follows: --- Westcort®
(hydrocortisone valerate) Cream, 0.2%,
NET Wt. 15 g,
WESTWOOD SQUIBB™, Rx
only, NDC 00072-8100-15, NSN 6505-01-093-9901,
BMS Item No. 8100-15 ---
Westcort® (hydrocortisone valerate) Cream, 0.2%, NET Wt. 45 g, WESTWOOD
SQUIBB™, Rx only, NDC 00072-8100-45, NSN 6505-01-083-9395, BMS Item No.
8100-45 ---
Westcort® (hydrocortisone valerate) Cream, 0.2%, NET Wt. 60
g, WESTWOOD
SQUIBB™, Rx only, NDC 00072-8100-60, NSN6505-01-121-0118, BMS
Item No.
8100-60,
b) Hydrocortisone Valerate Cream 0.2%
(generic) in 15 gram, 45 gram, and 60 gram
tubes, Rx only. The product is
labeled as follows:
15 g tube: NDC 59772-8100-7, BMS Item No. 810070,
Hydrocortisone Valerate
Cream 0.2%, NET WT. 15 g, Rx only, APOTHECON® ---
45 g tube: NDC 59772-8100-4, BMS Item No. 810040, Hydrocortisone Valerate
Cream 0.2%, NET WT. 45 g, Rx only, APOTHECON® --- NDC 0781-7059-19,
BMS
Item No. 705919, Hydrocortisone Valerate Cream 0.2%, Rx only, SANDOZ,
NET WT.
45 g, ---
60 g tube: NDC 59772-8100-5, BMS Item No. 810050, Hydrocortisone
Valerate
Cream 0.2%, NET WT. 60 g, Rx only, APOTHECON® --- NDC 0781-7059-35,
BMS Item No. 705935, Hydrocortisone Valerate Cream 0.2%, Rx only, SANDOZ,
NET WT. 60 g,
CODE
a) 15 g tube: Lots 81T013
(exp. date 7/06), 81U008 (exp. date 8/07), and 81U011
(exp. date 11/07) ---
45 g tube: Lots 81T018 (exp. date 9/06), 81U008 (exp. date 8/07), and 81W010
(exp. date 6/08) ---
60 g tube: Lots 81T015 (exp. date 9/06) and 81W010
(exp. date 6/08);
b) 15 g tube: Lot 81W001 (exp. date 1/08). ---
45 g
tube: Lots 81U002 (exp. date 3/07) and 81U006 (exp. date 5/07); Lot 81W011
(exp. date 6/08) ---
60 g tube: Lots 81T014 (exp. date 9/06), 81U005
(exp. date 5/07), and 81W002
(exp. date 1/08),
Lot 81W012 (exp. date
6/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Bristol-Myers Squibb Company, New Brunswick, NJ,
Manufacturer: Contract Pharmaceuticals Limited
Niagara, Buffalo, NY. .
REASON SUBPOTENT: Some lots did not meet the specification
for hydrocortisone-17 valerate throughout the labeled shelf life of the
product.
VOLUME OF PRODUCT IN COMMERCE 353,796
tubes
DISTRIBUTION Nationwide
WEEK ENDING JUNE 30
PRODUCT
a) Glyburide and
Metformin Hydrochloride tablets, 2.5 ng/500 mg, (10X10) 100 unit dose
tablets, Rx only, NDC 0172-5711-10;
b) Glyburide and
Metformin Hydrochloride tablets, 5 mg/500 mg, (10X10) 100 unit dose tablets,
Rx only, NDC 0172-5712-10,
CODE
a) Lot 133750, Exp. 4/06;
b) Lot 133749, Exp. 5/06;
RECALLING
FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Inc., Miami, FL
Manufacturer: IVAX
Pharmaceuticals, Inc., Cidra, PR
REASON Failed specification for one impurity.
VOLUME
OF PRODUCT IN COMMERCE 20,042/100 total
packages
DISTRIBUTION Nationwide
PRODUCT Propoxyphene Napsylate
and Acetaminophen Tablets USP, 100 mg/650, 1000 tablets per bottle, Rx only, NDC
0172-4980-80
CODE Lot 134402A,
Exp.12/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Inc., Miami, FL
Manufacturer: IVAX Pharmaceuticals, Inc.,
Cidra, PR
REASON Failed dissolution test
requirements.
VOLUME OF PRODUCT IN COMMERCE 957/1000 tablet
bottles
DISTRIBUTION Nationwide