AUGUST 2006
WEEK ENDING AUGUST 5
The Mentholatum Company Issues a Nationwide Recall of WellPatch® Cough & Cold Soothing Vapor Pads in the U.S.
The Mentholatum Company announced it is conducting a nationwide recall of
WellPatch® Cough & Cold Soothing Vapor Pads due to
potential serious adverse health effects that could result if the product is
ingested by a child removing the patch and chewing on it.
Consumers who
have WellPatch® Cough & Cold Soothing Vapor Pads should stop using them
immediately.
The product is
sold nationwide over-the-counter at pharmacies and retail stores. This recall
affects only the Cough & Cold Soothing Vapor Pads. 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 The Mentholatum Company Customer Service
Department at 1-877-636-2677 or visit http://www.wellpatch.com./
PRODUCT
a) Thyro-Tab (levothyroxine sodium), 0.50mg, packaged in 150,000-tablet drums
for further
packaging,
b) Levothroid (levothyroxine sodium tablets, USP) 50 mcg., packaged in
100- and 1,000-ct. bottles, RX, NDC
0456-1321-01(100 ct.) and
NDC 0456-1321-00 (1,000 ct).
CODE
a) HB20205, HC20205, and HD20205, all with an exp.
date of Aug 06;
b) Lot #080525 (100 ct.) from bulk lot HB20205,
Lot
#080526 from bulk lot HC20205 (100 ct.), and
Lot #090510 (1,000-ct.) from
bulk lot HD20205, all with an Aug 06 exp. date
RECALLING
FIRM/MANUFACTURER Lloyd Inc of Iowa, Shenandoah, IA
REASON Subpotent: The product failed stability at the 9-month test
interval.
VOLUME OF PRODUCT IN COMMERCE 5,831,211 bulk tablets
dist. by Lloyd; 38,149/100-ct. btls and 1,824/1,000-ct. btls. dist. by
Forest
DISTRIBUTION OH
PRODUCT
a) Fexofenadine
Hydrochloride, 60 mg tablets, 30-tablet box,
NDC# 61392-331-30,
b) Fexofenadine Hydrochloride, 60 mg tablets, 250-tablet bag,
NDC# 61392-331-25.
CODE
a) lot K43240R30, exp.
12-12-06;
b) lot K43240R25, exp. 12-12-06
RECALLING
FIRM/MANUFACTURER Heartland Repack Services LLC, Toledo, OH, REASON Packaging
mixup-The outer packaging is labeled as
Fexofenadine Hydrochloride 60 mg tablets, but the unit dose blister strips
inside the box may contain and be labeled Hydralazine Hydrochloride, 100 mg.
tablets.
VOLUME OF PRODUCT IN COMMERCE 1,841/30 count boxes &
18/250 count bags
DISTRIBUTION Nationwide
PRODUCT Lannett Morphine Sulfate
Concentrated Oral Solution, 120 mL bottle, NDC 0527-1425-62, 240mL bottle NDC
0527-1425-63,
CODE Lot numbers: 801-05066-010,
801-05073-011
RECALLING FIRM/MANUFACTURER Cody Laboratories, Inc.,
Cody, WY
REASON Subpotent: Drug failed assay specifications at 12
month stability testing.
VOLUME OF PRODUCT IN COMMERCE 7,044/120mL
bottles, 1,980/240mL bottles
DISTRIBUTION PA
PRODUCT
a)
Cilostazol, 100 mg
tablets, 30 tablet box, NDC # 66993-009-60;
b) Cilostazol, 100 mg tablets, 250 tablet bag, NDC # 66993-009-60 (ARE BOTH RECALLS
SUPPOSE TO HAVE THE SAME ND #)
CODE
a) Lot
K43243R30, exp. 12-13-06;
b) Lot K43242R25, exp. 12/13/06
RECALLING
FIRM/MANUFACTURER Heartland Repack Services LLC, Toledo, OH, REASON Packaging
mixup; The outer package is labeled as Cilostazol, 100 mg tablets, but the unit dose strips inside the outer packaging
may contain and be labeled as Benztropine Mesylate, 0.5 mg tablets.
VOLUME
OF PRODUCT IN COMMERCE 743/30 count boxes and 25/250 count
bags
DISTRIBUTION Nationwide
PRODUCT
a) Corn and Callus
Remover --- ½ ounce bottle --- OTC ---- Active Ingredient:
Salicylic acid
17% w/w. The product was distributed under the following
labels:
1)
Clay-Park Labs label: NDC 45802-239-61, UPC # 0-81642-23961;
2) CVS label:
NDC CVS-239-61, UPC # 0-50428-34534-4;
3) equaline label: NDC 41163-239-61,
UPC # 0-41163-26755-8;
4) Rite-Aid label: NDC RITE AID-239-61, UPC #
0-11822-31528.---
IMPROVED Corn & Callus Remover --- For External Use
Only ---
½ FL OZ (14 mL), Recall # D-307-6;
b) Wart Remover Solution ---
½ ounce bottle --- OTC --- Active Ingredient:
Salicylic acid 17% w/w. The
product was distributed under the following labels:
1) NDC 24385-236-63 --- UPC
# 87701-89434, Brite-Life® Wart
Remover Solution --- For the Removal of
Common Warts --- ½ FL. OZ.
(14 mL);
2) Clay-Park Labs label: NDC
45802-236-63, NSN-6501-01-121-2337,
UPC # 3-45802-236-63-0, -- Wart Remover
Liquid --- Salicylic Acid ---
NET CONT. ½ fl oz (14 mL);
3) CVS label:
CVS® pharmacy WART REMOVER --- FAST-ACTING LIQUID ---
SALICYLIC ACID --- ½
FL OZ (14 mL), CVS-236-63, UPC # 0-50428-21032-1;
4) Eckerd label: NDC
19458-6009-1, UPC # 0-34575-50697-1,
NDC 19458-6009-1 --- ECKERD Wart
Remover Liquid ---
Salicylic Acid 17% --- ½ FL OZ (14 mL);
5) equaline
label: NDC 41163-236-63, equaline wart remover liquid ---
net wt. 0.5 fl oz
(14 mL)UPC # 0-41163-26756-5;
6) equate label: equate® wart remover --- FOR
SAFE REMOVAL OF
COMMON WARTS --- 0.5 FL OZ (14 mL) NDC EQUATE-499-63,
UPC # 6-81131-76900-6;
7) Longs label: NDC 12333-9430-1 --- Longs
MAXIMUM STRENGTH ---
Wart Remover Solution ---NET CONT ½ fl oz (14 mL) ---
SALICYLIC ACID 17%
UPC # 3 12333-94301-6;
(8) RITE AID Liquid Wart
Remover --- ½ FL OZ (14 mL),
NDC RITEAID-236-63, UPC # 0-11822-31391-9,
CODE
a) All lots within expiry;
b) All
lots within expiry.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perrigo Company,
Allegan, MI,
Manufacturer: Pharma Pac, LLC, De Kalb, MS,
REASON Complaints from the market indicating the product
has been drying out thus leaving a crystallized substance.
VOLUME OF
PRODUCT IN COMMERCE 1,108,323 units
DISTRIBUTION Nationwide
PRODUCT Breckenridge
Pharmaceuticals Sulfatol Gel 5%, Sodium Sulfacetamide 10% and Sulfur 5% 1.5 Fl.
Oz.. (45 mL) Rx only, NDC 51991-172-45,
CODE Lot
Numbers: 50419E0307 and 50420EO307 Exp. 3/07
RECALLING
FIRM/MANUFACTURER Sheffield Laboratories, Div. of Faria Limited LLC, New
London, CT,
REASON Superpotent: sulfur levels exceeded the specifications of
4.5-5.5%.
VOLUME OF PRODUCT IN COMMERCE 26,736 units
DISTRIBUTION CT
PRODUCT Bausch & Lomb *
Advanced * Eye ReliefÔ * Opcon-Aâ * Allergy * 6.5 FL oz (15mL) *,
CODE
Lot GE 6024
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Inc.,
Rochester, NY,
Manufacturer: Bausch &
Lomb, Inc., Greenville, SC.
REASON Labeling: Product with the new trade dress (‘Advanced Eye
Relief) was distributed prior to receiving FDA approval.
VOLUME OF PRODUCT
IN COMMERCE 48,000 bottles
DISTRIBUTION Nationwide
WEEK ENDING AUGUST 12
PRODUCT
a) Hydralazine
Hydrochloride 100 mg tablets, 30 tablet box, NDC # 50111-397-01,
b) Hydralazine Hydrochloride 100 mg tablets, 250 tablet bag,
NDC
# 50111-397-01,
CODE
a) Lot K43263R30,
exp. 12/13/06;
b) Lot K43263R25, exp. 12/13/06
RECALLING
FIRM/MANUFACTURER Heartland Repack Services LLC, Toledo, OH,
REASON
Packaging mix-up- The outer packaging is
labeled as Hydralazine Hydrochloride, 100 mg tablets, but the unit dose blister
strips inside the outer packaging may contain and be labeled as Benztropine
Mesylate, 0.5 mg tablets.
VOLUME OF PRODUCT IN
COMMERCE 655/30 count boxes and 10/150 count
bags
DISTRIBUTION Nationwide
PRODUCT Lorazepam
Tablets, 2 mg, 30 tablet bingo cards, NDC # 61332-452-39,
CODE
Lot # 452E0622, expiration date
4/30/2007
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Heartland repack Services LLC, Toledo, OH,
Manufacturer: Sandoz, Inc, Broomfield, CO.
REASON
Lorazepam 1 mg
tablets packaged and distributed as Lorazepam 2 mg tablets.
VOLUME OF
PRODUCT IN COMMERCE 1,124 cards/30 tablets per
card
DISTRIBUTION Nationwide
PRODUCT Actonel® (risedronate sodium tablets), 35 mg, once a week, Rx only, NDC 0149-0472-02.
Each physician sample contains 1 tablet in a blister, sealed in a pouch, affixed
to a sample card,
CODE Lot 328121, exp.
date 12/2007
RECALLING FIRM/MANUFACTURER Procter &
Gamble Pharm, Inc., Norwich, NY,
REASON Labeling: Incorrect package
insert (older version) was sent instead of revised current
version.
VOLUME OF PRODUCT IN COMMERCE 229,034 physician
samples
DISTRIBUTION Nationwide
WEEK ENDING AUGUST 19
PRODUCT FDG F-18
Fluorodeoxyglucose Injection, 20 mCi/mL as of 7/18/06 7:00; 5 mL and 10 mL vials
CODE
Lot 140718061, exp. 7/18/06
15:28
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal
Health Inc., Dublin, OH
Manufacturer: Cardinal Health 420 LLC, Beltsville, MD.
REASON
Pharmaceutical for injection
was out of specification for endotoxin levels.
VOLUME OF PRODUCT IN
COMMERCE 3 vials
DISTRIBUTION MD
PRODUCT Extra Strength Super
Troche DM, each troche contains 15 mg Benzocaine and 10 mg Dextromethorphan HBr,
10 troches per bottle,
CODE 06039A1, Exp.
7/08
RECALLING FIRM/MANUFACTURER Weeks & Leo Co., Inc., Des
Moines, IA
REASON Drug Facts label on back of the bottle does not
list Dextromethorphan HBr as an active ingredient and lacks the warning not to
use the product if taking a monoamine oxidase inhibitor.
VOLUME OF PRODUCT
IN COMMERCE 509/10-troche
bottles
DISTRIBUTION Nationwide
PRODUCT Comfort Shield Personal
Cleansing Perineal Care Washcloths, Dimethicone 3%, supplied in 3, 8 and 24
count packages,
CODE Reorder #7503 - lot 1999;
reorder #7503-M - lots 1702 and 1995; reorder #7403 - lots 1301, 1312, 1457,
1651 and 1677; reorder #7408 - lot 1848; reorder #7905 - lot 1766; reorder #7524
- lots 2070 and 2086
RECALLING FIRM/MANUFACTURER Sage Products,
Inc., Cary, IL
REASON Microbial contamination; Burkholderia
cepacia
VOLUME OF PRODUCT IN COMMERCE 4,180 cases -- US, 7,468
cases - Canada
DISTRIBUTION Nationwide and Canada
PRODUCT Flumazenil Injection, 1
mg/10 mL (0.1 mg/mL), Sterile, Rx drug for I.V. use only; 10 mL multiple dose
vial; product code 402410, NDC #63323-424-10,
CODE Lot number 200324, expiration date
4/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis
Pharmaceutical Products, Rosemont, IL
Manufacturer: Abraxis Pharmaceutical Products, Melrose
Park,IL.
REASON Mispackaging: Some of the
boxes of Flumazenil Injection may contain vials of Levothyroxine Sodium for
Injection.
VOLUME OF PRODUCT IN COMMERCE 14,691
vials
DISTRIBUTION Nationwide and PR
WEEK ENDING AUGUST 26
PRODUCT ZOMIG (Zolmitriptan), 2.5
mg Tablets, Rx only, NDC 0310-0210-20
CODE Lot #
103158 Exp. Date: 09/2008
RECALLING FIRM/MANUFACTURER
Recalling
Firm: AstraZeneca Pharmaceutical LP, Wilmington, DE
Manufacturer: IPR Pharmaceutical, Inc., Carolina, PR.
REASON
Some blister cells may not
contain product.
VOLUME OF PRODUCT IN COMMERCE 42,192 blister packs
DISTRIBUTION Nationwide
PRODUCT GABAPENTIN *** Capsules
*** 300 mg *** Rx Only *** 2000 Capsules (Yellow/White) *** IVAX
Pharmaceuticals, Inc. ****** NDC 0172-4382-88 ***,
CODE Lot # 139631C, Expiration Date April
2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX
Pharmaceuticals, Miami, FL,
Manufacturer:
Ivax Pharmaceuticals, Inc., Cidra, PR.
REASON The Active Pharmaceutical Ingredient (API) does not
meet specifications.
VOLUME OF PRODUCT IN COMMERCE 1,373/2000 count
bottles
DISTRIBUTION Nationwide
WEEK ENDING AUGUST 31
PRODUCT
Azathioprine Tablets, USP, 50 mg, 100 tablet bottles, Rx only, NDC 0054-4084-25,
CODE
Lot #558470A, exp. date Mar 2009.
RECALLING
FIRM/MANUFACTURER Boehringer Ingelheim Roxane Inc, ColumbusOH,
REASON
Label Mixup; product labeled to
contain Azathioprine, 50 mg Tablets may actually contain Methotrexate, 2.5 mg
Tablets.
VOLUME OF PRODUCT IN COMMERCE 8,742/100 tablet
bottles
DISTRIBUTION Nationwide
PRODUCT
a) Triaminic Vapor Patch
Cough, Menthol Cough Suppressant, (menthol), 2.6%, Mentholated Cherry Scent,
6 Chest Patches per box and professional samples,
b)
Triaminic Vapor Patch Cough, Menthol Cough Suppressant, (menthol) 2.6%,
Menthol Scent, 6 Chest Patches per box and professional samples,
CODE
All products in commerce.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Novartis Consumer Health Inc.,
Parsippany NJ
Manufacturer: Novartis Consumer Health Inc, LincolnNB.
REASON
Misbranded; Use
of the product on young children can pose health risks due to potential
accidental ingestion.
VOLUME OF PRODUCT IN COMMERCE Mentholated
Cherry - 4,069,195/6-ct. boxes and 113,088/1-ct. professional samples; menthol -
857,026/6-ct. boxes
DISTRIBUTION Nationwide, Canada and Panama
PRODUCT
a) Extra Strength GENAPAP
Tablets, acetaminophen (APAP), 500 mg EACH, 100 count bottles, ASPIRIN-FREE,
PAIN RELIEVER/FEVER REDUCER, NDC 0182-1457-01,
b)
Extra Strength GENAPAP Caplets, acetaminophen (APAP), 500 mg EACH, 100 count
bottles, ASPIRIN-free, PAIN RELIEVER/FEVER REDUCER, NDC 0182-2152-01,
c) Extra Strength GENEBS Tablets, acetaminophen, 500 mg EACH, 100 and 1000 count bottles, PAIN RELIEVER/FEVER
REDUCER, NDC
0182-1832-01,
d) Extra Strength GENEBS Caplets,
acetaminophen, 500 mg EACH, 100 and 1000 count bottles, PAIN RELIEVER/FEVER REDUCER,
CODE
a) Lot Numbers: 5L020B;
b)
Lot Numbers: 5H018D;
c) Lot Numbers: 5J006A, 5F001, 5H007, 5H007B, 5L014,
5L018, 5L019;
d) 5B003, 5F002, 5F004A, 5H003A, 5H005, 5H015, 5H016, 5H018B, 5M024, 5M030A, 6A014, 6B022B, 5B016, 5F004,
5F010, 5F010C,
5H003, 5H018A, 5L009B, 5M008A, 5M030
RECALLING
FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, MiamiFL
REASON
Misbranded; the labeling on the product incorrectly
states, "do not take more than 12 caplets in 24 hours". The correct statement
should state, "do not take more that 8 caplets in 24 hours"
VOLUME OF
PRODUCT IN COMMERCE 211,955
DISTRIBUTION Nationwide and
PR
PRODUCT Bravelle®, urofollitropin
for injection, purified, 75 IU, Rx only, NDC 55566-8505-6. Box contains 5
product vials + 5 vials diluent + 5 vial adapters
CODE Lot: FMA038B-1, Exp. 5/07
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals, Inc.,
Suffern, NY
Manufacturer: Cardinal Health, Albuquerque, NM.
REASON
Stability sample tested at 3 months
exceeds specification for rate of oxidation of alpha subunits.
VOLUME OF
PRODUCT IN COMMERCE 648 boxes (5 vials per
box)
DISTRIBUTION Nationwide
CORRECTION
The corrections are as follows:
PRODUCT
a) Levoxyl ® (Levothyroxine
sodium tablets, USP), 75 mcg 100 count bottles, Rx Only, NDA: 21-301 NDC:
52604-5075-1,
b) Levoxyl ® (Levothyroxine sodium tablets, USP), 112mcg, 100 and 1000-count bottles, Rx Only,
NDA: 21-301 NDC: 52604-5112-1 and
52604-5112-2,
c) Levoxyl ® (Levothyroxine sodium tablets, USP), 125mcg, 100 and 1000-count bottles, Rx Only,
NDA: 21-301 NDC: 52604-5125-2 and 52604-5125-1,
CODE
a) Lot: 9240, SAP
batch 21272;
b) Lots: 9227 and
9248, SAPs 21274 and 21324;
c) Lots: 9222, 9228 and 9212. SAPs 21268, 21271
and 21267
RECALLING FIRM/MANUFACTURER
Recalling Firm: King
Pharmaceuticals, Inc., Bristol, TN,
Manufacturer: King Pharmaceuticals, Inc. (St. Petersburg
Facility), Saint Petersburg, FL.
REASON
Potential sub-potency at expiry.
VOLUME OF PRODUCT IN COMMERCE 108,351
DISTRIBUTION Nationwide and PR
PRODUCT Cocaine Hydrochloride Topical Solution 4 % packed in 4mL glass bottles,
CODE Lot: 656429A, Expiration Date: Apr 07, and Lot:
656795B, Expiration Date: May 07.
RECALLING
FIRM/MANUFACTURER Boehringer Ingelheim Corp., Columbus, OH,
REASON Mislabeling: The folding carton for the Cocaine
Hydrochloride 4% topical solution lists the incorrect milligram strength for the
product.
VOLUME OF PRODUCT IN COMMERCE 44,452
units
DISTRIBUTION Nationwide
PRODUCT Hydroxyzine Pamoate 25mg
Capsules, USP, Rx only, 500 capsules, NDC 0172-2911-70,
CODE Lot # 132379B Exp 10/2006
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, MiamiFL,
Manufacturer: Ivax Pharmaceuticals, Inc.,
CidraPR.
REASON Impurities/Degradation Products: For products
and/or lots, unidentified extraneous peaks were noted at chromatographic
analysis. Chromatographic analysis of extraneous peaks was determined to be
insufficient.
VOLUME OF PRODUCT IN COMMERCE 4,889 bottles of
500
DISTRIBUTION Nationwide
PRODUCT Nadolol 80mg Tablets USP,
100 Tablets, Rx only, Manufactured by: IVAX Pharmaceuticals, Inc., Miami, FL
33137, NDC 0172-4237-60,
CODE Lot # 141316A Exp
09/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax
Pharmaceuticals, MiamiFL.,
Manufacturer:
Ivax Pharmaceuticals, Inc., CidraPR.
REASON Impurities/Degradation Products: For products
and/or lots, unidentified extraneous peaks were noted at chromatographic
analysis. Chromatographic analysis of extraneous peaks was determined to be
insufficient.
VOLUME OF PRODUCT IN COMMERCE 3,487 bottles of 100
tablets
DISTRIBUTION Nationwide
PRODUCT Indomethacin 50mg
Capsules USP, 500 capsules,
CODE Lot # 139580A
Exp 07/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax
Pharmaceuticals, MiamiFL.,
Manufacturer:
Ivax Pharmaceuticals, Inc., CidraPR.
REASON Impurities/Degradation Products: For products
and/or lots, unidentified extraneous peaks were noted at chromatographic
analysis. Chromatographic analysis of extraneous peaks was determined to be
insufficient.
VOLUME OF PRODUCT IN COMMERCE 7,589 bottles of 500
count
DISTRIBUTION Nationwide
PRODUCT CIS-Sulfur Colloid (Kit
for the Preparation of Technetium Tc99m Sulfur Colloid Injection Diagnostic for
Intravenous and Oral Use, Each 10 mL multidose reaction vial contains in
lyophilized form 2.0 mg sodium thiosulfate anhydrous, 2.3 mg edtate disodium and
18.1 mg gelatin, Rx, Packaged under the CIS-US and private TSC Label,
CODE
Lots: 6443 through 6450.
RECALLING
FIRM/MANUFACTURER CIS-US, Inc., Bedford, MA
REASON Stability of product
is not assured to expiration.
VOLUME OF PRODUCT IN COMMERCE 128,425
vials
DISTRIBUTION Nationwide and Internationally