FEBRUARY 2005
WEEK ENDING FEBRUARY 5
PRODUCT
Power Plus Energy Supplement N-3, 4 oz;
Power Plus Energy Supplement C-3, 4 oz;
Power Plus Normal Kit; and
Power Plus Chemically Treated Kit.
CODE
Product Numbers: B18604, B18605, KT5520,
and KT5515. All lots remaining on the market.
RECALLING FIRM/MANUFACTURER
Farouk Systems, Inc., Houston, TX.
REASON
Unapproved new drug, hair regrowth claims,
contains minoxidil.
VOLUME OF PRODUCT IN COMMERCE
17,140 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Metoclopramide Tablets, USP, 5 mg tablets,
Rx only, packaged in 30 and 31 count grid cards.
NDC 0615-3546-39 and NDC 0615-3546-31.
b) Folic Acid Tablets, USP, 1 mg, Rx only,
packaged in 30 and 31 count grid cards.
NDC 0615-0664-39 and NDC 0615-0664-31.
CODE
a) Lot 3546-4009, exp. Date 10/31/05 and
Lot 3546-4009, exp. Date 10/31/05;
b) Lot 0664-4010, exp. Date 10/31/05 and
Lot 0664-4010, exp. Date 10/31/05.
RECALLING FIRM/MANUFACTURER
NCS Healthcare of Kentucky, Inc., Glasgow, KY.
REASON
Mislabeling, the outside grid card package is labeled as Metoclopramide, 5 mg,
however, individual blister packages contained within the grid cards are labeled
as, and contain, Folic Acid, 1 mg.
VOLUME OF PRODUCT IN COMMERCE
38,354 packages.
DISTRIBUTION
Nationwide.
PRODUCT
Biosilk Dandruff Control Conditioner 11.6 oz and 34 oz.
CODE
Product Numbers: BI9111 and BI9134. All lots remaining on the market.
RECALLING FIRM/MANUFACTURER
Farouk Systems, Inc., Houston, TX.
REASON
cGMP deficiencies.
VOLUME OF PRODUCT IN COMMERCE
1,413 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Premarin (conjugated estrogens) tablets USP, 0.625 mg, 100 count tablet bottles,
NDC # 0046-0867-81.
CODE
Lot #034039 and 040349.
RECALLING FIRM/MANUFACTURER
Amerisource Health Services Corp., Columbus, OH.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
48,883/100 tablet bottles.
DISTRIBUTION
Nationwide.
PRODUCT
USept Tablets, Urinary Antiseptic Antibacterial/Analgesic, Rx only, 100 count
tablets, NDC 51991-027-01.
CODE
Lots S04C01 (exp. 3/07), S04E05 (exp. 5/07), S04F03 (exp. 6/07).
RECALLING FIRM/MANUFACTURER
Syntho Pharmaceuticals, Inc., Farmingdale, NY.
REASON
Presence of foreign substance.
VOLUME OF PRODUCT IN COMMERCE
29,659 bottles.
DISTRIBUTION
Nationwide.
WEEK ENDING FEBRUARY 12
PRODUCT
a) Lafayette Baro-Cat Barium Sulfate Suspension USP, 1.5% w/w (w/v) barium sulfate,
USP, Net
Contents: 300mL, 900mL and 1900mL bottles,
Rx only, Distributed in Canada by: Tyco
Healthcare, Montreal Quebec, Canada, Made
in Mexico.
b) Lafayette Cheetah Barium Sulfate Suspension,
2.2% w/w barium sulfate USP, Net Contents: 250mL,
450mL, 900mL, and 1900mL bottles, Rx only. Made
in Mexico.
c) NovaPlus Colon Barium - Air Contrast Barium
Sulfate Suspension, 100% w/v (55% w/w) barium
sulfate USP, Net Contents: 1900mL bottles,
Rx only, Made in Mexico.
d) NovaPlus CT Barium Sulfate Suspension, 1.5%
w/w (w/v) barium sulfate, Net Contents: 450mL
bottles, For Computed Tomography, Rx only,
Made in Mexico.
e) NovaPlus CT Barium-Fast Transit Barium
Sulfate Suspension, 2.2% w/w barium sulfate USP, For Computed Tomography, Net Contents:
450mL bottles, Rx only, Made in Mexico.
f) Lafayette Entrobar Barium Sulfate Suspension,
50% w/v barium sulfate suspension, Net Contents:
500mL bottles, Rx only.
g) Lafayette Entrocel Methylcellulose Solution,
1.5% w/w hydroxypropyl methylcellulose solution,
Net Contents: 500mL bottles, Rx only, Made in
Mexico.
h) Lafayette Entro-Ease Barium Sulfate Suspension,
15% w/v (12% w/w) barium sulfate, Net Contents:
600mL bottles, Rx only, Made in Mexico.
i) Lafayette Entro-Ease Barium Sulfate Suspension,
15% w/v (12% w/w) barium sulfate, Net Contents:
600mL bottles, Rx only, Made in Mexico.
j) Lafayette Liqui-Coat HD Barium Sulfate
Suspension, 210% w/v (81% w/w) barium sulfate,
Net Contents: 150 mL unit dose bottles, Rx only,
Made in Mexico.
k) Lafayette Liquid Barosperse Barium Sulfate
Suspension, 60%w/v barium sulfate, Net
Content: 355mL and 1900mL bottles, Rx only,
Made in Mexico.
l) Lafayette Flo-Coat Barium Sulfate Suspension,
100% w/v (55% (w/w) suspension of barium
sulfate USP, Net Contents: 1850mL, Rx only.
m) HD 85 Barium Sulfate Suspension, 85% w/v
suspension of barium sulfate USP, Net
Contents: 1900 mL bottles, Rx only.
n) Medebar Plus Barium Sulfate Suspension,
100% w/v suspension of barium sulfate USP,
Net Content: 650mL and 1900mL bottles, Rx only.
o) Medescan Barium Sulfate Suspension USP,
2.2% w/w (2.3% w/v), Net Content: 250mL,
450mL and 1900mL bottles, Rx only.
p) Prepcat Barium Sulfate Suspension, 1.5% w/w
(w/v) barium sulfate USP, Net Contents: 450mL
bottles, For Computed Tomography, Rx only.
Made in Mexico,
q) Lafayette Entrokit Enteroclysis Kit with
Catheter, Kit contains: Reglan (metoclopramide
hydrochloride) 10mg (metoclopramide base)
Tablets, 2% lidocaine hydrochloride, viscous
solution, Entrobar 50% w/v barium sulfate
suspension, Entrocel methylcellulose solution.
r) Lafayette Intropaste Barium Sulfate Paste,
(barium sulfate, USP), 70% w/v (44% w/w),454
gm tubes, Rx only, Made in Mexico.
s) Entrokit Enteroclysis Kit, Contents: Drugs:
Rx only, Reglan, metoclopramide hydrochloride,
10mg (metoclopramide base) tablets, 2%
Xylocaine, lidocaine hydrochloride, viscous
solution, Entrobar, 50% w/v barium sulfate
suspension, Entrocel, methylcellulose solution
concentrate.
t) Novaplus Liquid Barium - Single Contrast Barium
Sulfate Suspension, 50% w/v barium sulfate USP,
1900 mL bottles, Rx Only, Made in Mexico.
u) Scan C Barium Sulfate Suspension, 2.1% w/w for
computed tomography (CT) exams, 250 mL bottle,
Preservative Free, Rx only.
v) EVACU-PASTE 100, Barium Sulfate Paste
(100% w/v,56%w/w), Contents: 12 x 454 g
Cartridges, 12 Tip Assemblies and 1 Cutter,
Rx Only.
CODE
a) Lot Numbers: 300mL: 409316, 411485, 411486,
411489 -- 900mL: 406112 - 406114, 409313 -
409315, 409321- 409349, 410429, 410435, 411487,
411488, 411490 -- 1900mL: 407203, 409350;
b) Lot Numbers: 250mL: 031145 - 031147, 406102,
407148, 410378, 410416, 411465, 411466 -
450mL: 031145 - 031147, 040318 - 040340,
040430 - 040441, 040477, 040549 - 040551,
406029 - 406034, 407132 - 407137, 408269,
408271 - 408282, 408292, 408293, 409303,
409304, 409356 - 409358, 410369 - 410373,
410391, 410404, 401420 - 410427, 411467 -
411474 -- 900mL: 031145 - 031147, 040424 -
040429, 406035, 406036, 406103 - 406105,
407149, 409363 - 409365, 410374 - 410377,
410428 -- 1900mL: 031145 - 031147, 410379,
410380, 411475, 412612;
c) Lot Numbers: 040456, 410384;
d) Lot Numbers: 040542, 040543, 409320;
e) Lot Numbers: 040541, 040574, 040575, 406083 -
406086, 410383, 410432 - 410434;
f) Lot Numbers: 040115 - 040117, 410381, 410382,
412615, 412616;
g) Lot Numbers: 040119 - 040121, 406092;
h) Lot Numbers: 031026, 031027, 031028, 040442,
040443, 406093, 407205, 407206, 411464, 411484,
412581, 412587;
i) Lot Numbers: 031263 - 031265, 040578 - 040581,
407180 - 407182, 411437, 412565, 412624, 412625;
j) Lot Numbers: 355mL: 040582, 040583, 406037,
407192, 407193, 407216, 410381, 412562, 412566,
412567 -- 1900mL: 040584, 040585, 406051,
407189 - 407191, 407217, 411440, 412563;
k) Lot Numbers: 031033, 031034, 031035, 031037,
407150 - 407154, 410414, 410415, 411443, 411444,
411498 - 411500;
l) Lot Numbers: 410400, 412611;
m) Lot Numbers: 650mL: 031138, 031139, 031252,
040576, 040577, 406014, 406100, 406101, 410402,
410403 -- 1900mL: 031255 - 031257, 040341,
040342, 407171 - 407173;
n) Lot Numbers: 250mL: 407204, 410398, 412626 -
450mL: 040373 - 040375, 040463 - 040465, 040480,
040544 - 040548, 406024 - 406028, 407126, 407127,
407220, 409343 - 409346, 410390, 410396, 410397,
411491 - 411494, 412582 - 412585 -
1900mL: 410399, 412586;
o) Lot Numbers: 405002 - 405006, 406053 - 406056,
409317 - 409319, 409336-409338, 410386 - 410389,
410412 - 410413, 412613, 412614;
p) Lot Number: 040804-01;
q) Lot Numbers: 030614-1 - 030616-8, 040388-1 -
040562-8, 406081 - 409335-8;
r) Lot Numbers: 040511-01, 041111-01;
s) Lot Numbers: 506052, 512564, 512658;
t) Lot Numbers: 030717-1 - 031267-4, 040122 - 040125,
040234-1 - 040540-4, 406087-1 - 411462-1;
u) Lot Numbers: 406065-1 through 406076-4.
RECALLING FIRM/MANUFACTURER
Kendall Healthcare Products Co, Mansfield, MA.
REASON
Microbial contamination; product may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
165,000 cases or 2.2 million units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Carboplatin Injection, Each mL contains 10mg carboplatin and water for Injection,
50 mg/5 mL (10 mg/ml), 5mL Single Dose Vial, For IV Infusion. NDC 55390-220-01.
CODE
Lot #589490B.
RECALLING FIRM/MANUFACTURER
Bedford Laboratories, Bedford, OH.
REASON Mispacked; outer carton labeled as Carboplatin Injection 50mg/5mL vial actually
contains Carboplatin Injection 150mg/15mL vial.
VOLUME OF PRODUCT IN COMMERCE
60 vials.
DISTRIBUTION
IL, OH, NJ, MI, MO, MN, and WA.
PRODUCT
Paxil Tablets (paroxetine hydrochloride), 10mg scored tablets, 30 count bottles,
Rx only. NDC 0029-3210-13.
CODE
Lot Number: F61-4B10; Expiration date: 31 July 2006.
RECALLING FIRM/MANUFACTURER
Sb Pharmco Puerto Rico Inc., Cidra, PR.
REASON Subpotent; 3 month stability.
VOLUME OF PRODUCT IN COMMERCE
78,000 bottles.
DISTRIBUTION
Nationwide.
PRODUCT Desyrel Dividose Tablets (tranzodone HCL) 150 mg, 100 count bottle, Rx only. NDC 0087-0778-43.
CODE
Lot # 4F83245, Exp. date 6/30/2007.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Manufacturing Co, Mayaguez, PR.
REASON
Good Manufacturing Practice Deviation; Quarantine drum of active ingredient
was inadvertently used for production.
VOLUME OF PRODUCT IN COMMERCE
242 bottles/100 tablets.
DISTRIBUTION
Nationwide.
Alliant Pharmaceuticals Expands Its Voluntary Nationwide Recall of Methylin® CT, 2.5mg, 5mg, and 10mg tablets Methylphenidate-based product being voluntarily recalled because of possible health risk
Alliant Pharmaceuticals, Inc. is expanding its voluntary recall of Methylin® (Methylphenidate HCl) Chewable Tablets to include all lots of the product. The nationwide recall now includes all 2.5 mg, 5 mg and 10 mg dosage strengths because some tablets may contain too much or too little active ingredient.
The company initially elected to recall one lot of 5 mg product, lot #AMT50402A, from the market on January 14, 2005, because it was determined that some tablets may contain up to three times the required amount of active ingredient. After further investigation, the manufacturer, Mallinckrodt, Inc., of St. Louis, MO, determined that there was potential for other lots to contain superpotent and subpotent tablets. Upon Mallinckrodt's further investigation they found that the potential problem was the result of a manufacturing mixing issue and not due to the medication's active ingredient.
Methylin® (Methylphenidate HCl) Chewable Tablets are a therapy for Attention Deficit Hyperactivity Disorder and Narcolepsy. The drug is sold in 100-tablet bottles and dispensed to patients in amounts prescribed by a physician.
The company is notifying wholesalers and pharmacists of the recall by letter. They are asking pharmacists to attempt to notify patients who were dispensed prescriptions from their pharmacy. Distributors and pharmacies should promptly quarantine any product with the following lot numbers:
2.5 mg (NDC 68188-132-01)
Lot numbers:
AMT20401A,
AMT20402A, AMT20403A, AMT20404A
5 mg (NDC 68188-135-01)
Lot
numbers:
AMT50401A, AMT50402A (previously recalled),
AMT50403A, AMT50404A
10 mg (NDC 68188-137-01)
Lot numbers:
AMT100401A, AMT100402A, AMT100403A, AMT100404A
Alliant's liquid form of the product -- Methylin® Oral Solution (5mg / 5mL and 10mg / 5mL strengths) -- is not affected by the recall and is still widely available. In addition, Mallinckrodt's Methylin® ER or Methylin® immediate release products are not affected by this recall.
Patients should call their pharmacists or physicians if they have questions about the recall. Health care providers or patients who have questions can contact Alliant Pharmaceuticals, at 770-817-4500 or visit www.alliantpharma.com.
WEEK
ENDING FEBRUARY 19
PRODUCT
a) Lupron Depot Injection (leuprolide acetate for
depot suspension) 7.5mg, Single Dose
Administration Kit with prefilled dual-chamber
syringe, IM injection, Rx Only, Kit includes:
One prefilled dual chamber syringe containing
needle with LuproLoc safety device and plunger.
NDC 0300-3642-01.
b) Lupron Depot Injection (leuprolide acetate for
depot suspension), 4 Month 30mg, Single Dose
Administration Kit with prefilled dual-chamber
syringe, IM injection, Rx Only, Kit includes:
One prefilled dual chamber syringe containing
needle with LuproLoc safety device and one plunger.
NDC 0300-3683-01.
CODE
a) Lot 20119AP21;
b) Lot 20117AP21.
RECALLING FIRM/MANUFACTURER
Tap Pharmaceutical Prod, Lake Forest, IL.
REASON Subpotent; clumping of the powdered medication in the diluent may interfere
with delivery of the full therapeutic dose.
VOLUME OF PRODUCT IN COMMERCE
16,275 syringes.
DISTRIBUTION
Nationwide.
PRODUCT
Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Ciprofloxacin hydrochloride 3.5
mg equivalent to 3 mg base; Rx only, sterile ophthalmic solution for topical
ophthalmic use only in 5 mL plastic dispenser bottle, 10 bottles per shelf pack.
NDC 60505-1000-1.
CODE
Lot numbers GM9408, GM9410, GM9412.
RECALLING FIRM/MANUFACTURER
Apotex Corp, Lincolnshire, IL
REASON
Impurities/Degradation: Degradation level exceeds specification requirement
of less than 0.2% impurities.
VOLUME OF PRODUCT IN COMMERCE
121,071 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Ipratropium Bromide Inhalation Solution, 0.02%, 0.5mg/vial, 30 Sterile 2.5mL
Unit-Dose Vials, For oral inhalation only, Rx only, Sterile, NDC 0487-9801-01.
CODE
Lot Number P4174A.
RECALLING FIRM/MANUFACTURER
Nephron Pharmaceuticals, Corp, Orlando, FL.
REASON
Mislabeling: a single vial of Albuterol Sulfate Inhalation Solution found in
Ipratropium Bromide Inhalation Solution, 0.02% pouches.
VOLUME OF PRODUCT IN COMMERCE
9,640 carton of 30 vials each (289,200 vials).
DISTRIBUTION
Nationwide.
PRODUCT
Ethex Corporation Anemagen OB Prenatal Multivitamin and Mineral Soft Gelatin
Capsules, 1 mg folic acid and 1.6 mg Vitamin B1, 100 capsules per bottle, Rx
only.
CODE
Lot #62800, Exp. 05-2006.
RECALLING FIRM/MANUFACTURER
Ethex Corporation, Bridgeton, MO
REASON Superpotent: The batch was formulated above the USP limit for folic acid and
thiamine mononitrate.
VOLUME OF PRODUCT IN COMMERCE
1,462/100-capsule bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Prascion Cleanser, (sodium sulfacetamide10% and sulfur 5%), Cleanser, Rx only,
6 oz (170.3g),
CODE
Lot #GB430.
RECALLING FIRM/MANUFACTURER
Kiel Laboratories, Inc., Gainesville, GA,
REASON Subpotent: sulfur (12 month stability).
VOLUME OF PRODUCT IN COMMERCE
3,609 bottles.
DISTRIBUTION
OH.
PRODUCT
K-Tan 4 Suspension, Each 5mL (one teaspoonful) contains: Phenylephrine Tannate
5mg, Pyrilamine Tannate 30mg, 4 fl oz (ll8mL) bottles, Rx only. NDC 66993-521-55.
CODE
Lot #GB643.
RECALLING FIRM/MANUFACTURER
Kiel Laboratories, Inc., Gainesville, GA
REASON Subpotent: phenylephrine tannate (24 month stability).
VOLUME OF PRODUCT IN COMMERCE
6,493 bottles.
DISTRIBUTION
OH.
PRODUCT
Double Tussin DM Cough/Cold Syrup, (Dextromethorphan HBr 20 mg and Guaifenesin
300 mg), OTC, 4 oz. amber PET bottles with a white child resistant screw cap
and tamper evident neck band.
CODE
Lot K0429, Exp. 10/06.
RECALLING FIRM/MANUFACTURER
Medico Labs, Inc., Hamilton, NJ.
REASON
Presence of Precipitate.
VOLUME OF PRODUCT IN COMMERCE
7,740 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
a) Premarin (conjugated estrogens) tablets, USP, 0.9 mg, 100 tablet bottles, Rx,
NDC 0046-0864-81.
b) Prempro (conjugated estrogens/medroxyprogesterone
acetate) tablets, 0.45 mg/1.5 mg, shipped in
cartons containing 3 EZ DIAL Dispensers of 28
tablets each, Rx. NDC 0046-0937-09.
CODE
a) A49687, Exp. 01/2006;
b) A49710, Exp. 06/2005, A80422, Exp. 06/2005,
and A80424, Exp. 06/2005.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
88,224 bottles Premarin; 74,521 cartons Prempro.
DISTRIBUTION
Nationwide.
WEEK ENDING FEBRUARY 26
PRODUCT
Megace Oral Suspension (megestrol acetate) Each mL contains 40 mg of micronized
megestrol acetate in a lemon-lime flavored oral suspension, 240 mL (8fl. Oz.)
bottle, Rx only, NDC 0015-0508-42.
CODE
Lot 3K75331 Exp. Date 10/05; Lot 3K75337 Exp. Date 11/05; Lot 3K79118 Exp. Date
11/05; Lot 3L68577 Exp. Date 11/05; Lot 3L73761 Exp. Date 11/05.
RECALLING FIRM/MANUFACTURER
Bristol Myers Squibb Caribbean Company, Mayaguez, PR.
REASON
Product contains microbial contamination; mold and yeast.
VOLUME OF PRODUCT IN COMMERCE
23,439 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
a) Nefazodone HCl Tablets, 50 mg, 100 count
bottles, Rx only.
b) Nefazodone HCl Tablets, 100 mg, 100 count
bottles, Rx only.
c) Nefazodone HCl Tablets, 150 mg, 100 count
bottles, Rx only.
d) Nefazodone HCl Tablets, 200 mg, 100 count
bottles, Rx only.
CODE
a) Lot 118557A, Exp. Date 6/2005;
b) Lot 118550, Exp. Date 7/2005;
c) Lot 118552, Exp. Date 6/2005;
d) Lot 118555, Exp. Date 7/2005.
RECALLING FIRM/MANUFACTURER
Ivax Pharmaceuticals, Inc., Northvale, NJ.
REASON
Dissolution Failure: Lots may fail to meet requirements for dissolution throughout
expiration.
VOLUME OF PRODUCT IN COMMERCE
a) 50 mg-949 units;
b) 100 mg-937 units;
c) 150 mg-1348 units;
d) 200 mg-1316 units.
DISTRIBUTION
Nationwide.
PRODUCT
Madame Pearl's brand Cough Syrup, OTC product. Product is amber liquid packed
in a clear glass 120 ml bottle with a red cap, and green and white adhesive
labels on the front and back of the bottle.
CODE
Old code: PD/BAT 19990805 Exp. D 20011105;
New code: PD/BAT 20030805 Exp.D20070605.
RECALLING FIRM/MANUFACTURER
Great Kingsland, Inc., Brooklyn, NY
REASON
The product has exceeded the label expiration date, and has been re-labeled
with a new production and expiration date without any supporting data.
VOLUME OF PRODUCT IN COMMERCE
5 cases (6 x 12 bottles).
DISTRIBUTION
PA, IL, and MA.
PRODUCT
Premarin 0.625 mg (Conjugated Estrogens Tablets, USP), Rx only, NDC 0046-0867-91.
CODE
Lot # 09748, Exp. 09/05; Lot 09913, Exp. 09/05; Lot 09912, Exp. 09/05; Lot 09911,
Exp. 09/05; Lot 10043, Exp. 09/05; Lot 09749, Exp. 09/05.
RECALLING FIRM/MANUFACTURER
Rx PAK, Memphis, TN.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
15,000,600 bottles of 100 tablets.
DISTRIBUTION
Nationwide.
PRODUCT
Premarin 0.625 mg (Conjugated Estrogens Tablets, USP), Rx only.
CODE
Lot 08890, Exp. 09/05; Lot 08946, Exp. 09/05; Lot 08947, Exp. 09/05; Lot 06901,
Exp. 03/05; Lot 07217, Exp. 03/05; Lot 07218, Exp. 03/05; Lot 08029, Exp. 03/05.
RECALLING FIRM/MANUFACTURER
Rx PAK, Memphis, TN
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
210,581 bottles of 100 tablets.
DISTRIBUTION
Nationwide.