WEEK ENDING MARCH 5

MARCH 2006

WEEK ENDING MARCH 4

PRODUCT Methotrexate for Injection, USP, 1 Gram, Single Use Vial, Sterile, Lyophilized, Preservative-Free Cytotoxic Agent, Rx Only. NDC #55390-143-01
CODE Lot #859142, Exp. 09/07
RECALLING FIRM/MANUFACTURER Bedford Laboratories, Bedford, OH
REASON Chemical Contamination; product contains low levels of ethylene glycol.
VOLUME OF PRODUCT IN COMMERCE 8,570 vials
DISTRIBUTION Nationwide and PR

PRODUCT Campral Delayed-Release Tablets, (acamprosate calcium), 333 mg, packaged in 180-ct. bottles and 180-ct. dose packs (3/60-tablet blister cards per box), Rx only, NDC #0456-3330-01, CODE
Lot #P09190, Exp. 08/07;
Lot #110437, Exp. 08/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals, Inc., Earth City, MO
Manufacturer: Merck Sante SAS, Lyon, France
REASON Dissolution failure (12 month stability).
VOLUME OF PRODUCT IN COMMERCE 1,762/180-ct. bottles and 1,812/180-ct. dose packs
DISTRIBUTION Nationwide

PRODUCT Hydromorphone HCI U.S.P. C-II 1000 G bottles, WARNING: MAY BE HABIT FORMING, CAS 71-68-1, NDC #65893-300-**
CODE Lot #300-05047-161
RECALLING FIRM/MANUFACTURER Cody Laboratories, Inc., Cody, WY
REASON Exceeded Impurity Specification (isopropyl alcohol)
VOLUME OF PRODUCT IN COMMERCE 9507.2g
DISTRIBUTION CA, CO, IL, MN, PA

WEEK ENDING MARCH 11

PRODUCT
a) Carbidopa and Levodopa Extended-Release Tablets, 50 mg/ 200 mg, Rx only, 310 (10x31) unit-dose tablets. The product is packaged as 10 packages/31 packs per package (310 total tablets) in a clear plastic bag. Only the outer bag is labeled,
b) Carbidopa and Levodopa Extended-Release Tablets, 50 mg/ 200 mg, Rx only, 30 tablet unit dose
blister pack. NDC 0615 4568 39
c) Carbidopa and Levodopa Extended-Release Tablets, 50 mg/ 200 mg, Rx only, 31 tablet unit dose
blister pack. NDC 0615 4568 31
CODE
a) Lot #4568-5003, 4568-5004, 4568-5006, 4568-5008, 4568-5009;
b) Lot #4568-5003, 4568-5004, 4568-5005, 4568-5006, 4568-5007, 4568-5010, 4568-5011, 4568-5012;
c) Lot #4568-5003, 4568-5004, 4568-5005, 4569-5006, 4568-5008, 4568-5009
RECALLING FIRM/MANUFACTURER
Recalling Firm: NCS Healthcare of Kentucky Inc, Glasgow, KY,
Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV.
REASON The incorrect stability test method was used to assure that the product meets its specifications throughout its shelf life.
VOLUME OF PRODUCT IN COMMERCE 142/10 x 31 count cards, 7,875/31 count cards, 45,054/30 count cards
DISTRIBUTION Nationwide

PRODUCT
a) Carbidopa and Levodopa Extended-Release Tablets, 50 mg/200 mg. The product is packaged as 250 tablets per bag, NDC #61392-647-25
b) Carbidopa and Levodopa Extended-Release Tablets, 50 mg/200 mg. The product is
packaged as 30 tablets per box, NDC #61392-647-30
c) Carbidopa and Levodopa Extended-Release Tablets, 50 mg/200 mg. The product is
packaged as 60 tablets per box, NDC #61392-647-60
CODE
a) Lot K36341R25, U37262B25, U38484C25, U36886A25, U38484A25, U38484D25, U39499B25;
b) K36341R30, K38972B30, U36886A30, U37725A30, U38484B30, U39499A30, K38972A30, K39542A30, U37262A30, U37947A30, U38484E30;
c) K36341R60
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Repack Services LLC, Toledo, OH
Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV.
REASON The incorrect stability test method was used to assure that the product meets its specifications throughout its shelf life.
VOLUME OF PRODUCT IN COMMERCE 13,252/30 count boxes, 983/60 count boxes, 619/250 count bags
DISTRIBUTION Nationwide

PRODUCT Citalopram Hydrobromide 20 mg, 100 Tablets, Rx only, NDC 0172-4741-60
CODE Lot 136715D Exp. Date 12/2007
RECALLING FIRM/MANUFACTURER Ivax Pharmaceuticals, Inc., Cidra, PR
REASON Mislabeling: incorrect expiration date on the label.
VOLUME OF PRODUCT IN COMMERCE 7,032 bottles (100 count)
DISTRIBUTION Nationwide

PRODUCT
a) Carbocaine 1.5% mepivacaine hydrochloride injection USP, 15 mg/mL in 30 mL single dose
vial, Rx only, Sterile Injection For peripheral nerve block, caudal and epidural anesthesia,
NDC 0074-1041-30
b) Carbocaine 2% mepivacaine hydrochloride injection USP, 20 mg/mL in 20 mL single dose
vial and 50 mL multiple dose vials, Rx only, Sterile Injection, For peripheral nerve block,
caudal and epidural anesthesia, 20 mL vial: NDC 0074-1067-20, 50 mL vial: NDC 0074-2047-50,
c) Trimethobenzamide HCl Injection, USP, 200 mg/2 mL (100 mg per mL), 2 mL Carpuject
Sterile Cartridge Unit with Luer Lock, 10 units per carton, Rx only, For Intramuscular
Use Only, NDC 0074-1952-32
d) Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial,
Rx only, Sterile Solution For Intravenous Injection Only, NDC 0074-2267-20,
e) Cefazolin for Injection (lyophilized), equivalent to 1 gram cefazolin; Single-dose ADD-Vantage
Vial, 25 vials per carton, Rx only, For I.V. Infusion Only, Note: For use only with ADD-Vantage
Flexible Diluent Container; NDC 0074-4732-03,
f) Ketorolac Tromethamine Injection, USP, 60 mg (30 mg/mL, Rx only, packaged in

   a) 2 mL single-dose Carpuject Sterile Cartridge Unit with Luer Lock -- NDC 0409-2287-61 and
   b) Amerinet Choice, 2 mL single-dose fliptop vials, NDC 0409-3796-61, 25 vials per carton,
       Sterile Injectable Anti-Inflammatory, For I.M. Use Only
g) Dobutamine Injection, USP, each mL contains 12.5 mg dobutamine, as the hydrochloride, 250
mg per 20 mL, 20 mL single-dose fliptop vial, 10 vials per carton, must be diluted prior to
use, For I.V. Use Only, Rx only, Sterile Cardiotonic; NDC 0409-2344-02,
h) Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL single dose fliptop vial, 25 vials
per carton, Rx only, For I.M. or I.V. Use, dilute before I.V. use; NDC 0409-4052-01,
CODE
a) Lot 29-245-3A, exp 11/1/2007;
b) Lot 21-335-3A, exp 3/1/2007, Lot 26-220-3A, exp 8/1/2007;
c) Lot 32-510-3B, exp 8/1/2006;
d) Lot 34-065-3A, exp 8/1/2007;
e) Lot 29-203-DA, exp 3/1/2007;
f) Lot 26-546-LL, exp 2/1/2006,Lot 33-289-DK, exp 7/1/2007;
g) Lot 33-272-DK, exp 3/1/2007;
h) Lot 33-428-DK, exp 3/1/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL
Manufacturer: Hospira, Inc., Rocky Mount, NC
REASON Lack of Efficacy; the affected lots were initially received in a frozen state. The labeling claim for these products does not support their use when frozen.
VOLUME OF PRODUCT IN COMMERCE 2,240 units
DISTRIBUTION OH

PRODUCT
a) Dollar General Night Time Original Flavor Multi-Symptom Cold/Flu Relief, Part Number
FP-05-103-41310
b) Dollar General Night Time Cherry Flavor Multi-Symptom Cold/Flu Relief, Part Number
FP-05-103-71210
CODE
a) Lot numbers(expiration dates): 2932(08/2007), 22933(08/2007), 23180(08/2007), 24179(10/2007), 24222(10/2007), 24306(11/2007), 24361(11/2007), 24479(11/2007), 24753(12/2007), & 24848(01/2008);
b) Lot numbers(expiration dates): 22935 (08/2007), 23183(08/2007), 23496(08/2007), 24129(10/2007), 24224(10/2007), 24308(11/2007), 24484(11/2007), 24608(12/2007), 24689(12/2007), & 24776(12/2007)
RECALLING FIRM/MANUFACTURER Aaron Industries, Inc., Lynwood, CA
REASON Misbranding: The identified lots are misbranded in that the Principal Display Panel (PDP) of each of the products' label identifies the Antihistamine contained within the product as Chlorpheniramine Maleate whereas the Antihistamine actually contained within the product as well as identified within the Drug Facts portion of the labeling is Doxylamine Succinate.
VOLUME OF PRODUCT IN COMMERCE 253,746
DISTRIBUTION Nationwide

PRODUCT TriNessa (Norgestimate and Ethinyl Estradiol) Tablets, Oral Contraceptive, packaged in unit dose PVC blisters with an aluminum foil backing, Rx only, NDC 52544-935-28,
CODE
Lot -- Exp: 4CM613 -- MARCH 2006;
4CM614 -- MARCH 2006;
4KM005 -- AUGUST 2006;
4LM024 -- AUGUST 2006;
4LM025 -- AUGUST 2006;
4LM048 -- AUGUST 2006;
4MM101 -- SEPTEMBER 2006;
4MM109 -- SEPTEMBER 2006;
4MM110 -- OCTOBER 2006;
5AM165 -- OCTOBER 2006;
5AM166 -- OCTOBER 2006;
5CM286 -- JANUARY 2007;
5CM294 -- JANUARY 2007;
5CM295 -- JANUARY 2007;
5DM359 -- FEBRUARY 2007;
5EM416 -- MARCH 2007;
5GM426 -- FEBRUARY 2007;
5GM443 -- FEBRUARY 2007;
5GM477 -- APRIL 2007;
5JM547 -- MAY 2007;
5KM623 -- MAY 2007;
5LM657 -- MAY 2007;
5LM658 -- SEPTEMBER 2007
RECALLING FIRM/MANUFACTURER OMJ Pharmaceuticals, Inc., Manati, PR
REASON Subpotent: The active Norgestimate component of TriNessa tablets fails stability assay.
VOLUME OF PRODUCT IN COMMERCE 1,383,709/6 packs
DISTRIBUTION Nationwide

PRODUCT Wyeth brand FiberCon calcium polycarbophil, 626 mg., bulk-forming laxative, 36 caplets in blister packs, OTC.
CODE Lots 6AI0162, 5LE0563, 5KE1121, 5KE1122 and 5KE1123
RECALLING FIRM/MANUFACTURER Perrigo Company, Allegan, MI
REASON Stability data does not support expiration date.
VOLUME OF PRODUCT IN COMMERCE 21,972 packs
DISTRIBUTION Nationwide

WEEK ENDING MARCH 18

Inverness Medical Nutritionals Group Announce Recall of Iron Supplements

Name of Product: Walgreens High Potency Iron Supplement

Units: About 64,000

Manufacturer: Inverness Medical Nutritionals Group, of Freehold, N.J.

Hazard: The iron supplements are not in child-resistant packaging as required by the Poison Prevention Packaging Act. Ingesting multiple iron supplements at once can cause serious injury or death to young children.

Description: The recalled supplements were sold in a brown plastic bottle. “Walgreens Finest High Potency Iron Supplement” is printed on the yellow and green label on the bottle.

Sold at: Walgreens retail stores nationwide from April 2005 through October 2005 for about $5.

Manufactured in: U.S.

Remedy: Consumers should keep this product out of reach of children and return it to Walgreens for a free replacement.

Consumer Contact: For additional information or for a free replacement cap, contact Inverness at 1-(888) 698-5032 between 9 a.m. and 5 p.m. ET Monday through Friday. Consumers also may visit http://www.walgreens.com/recall/default.jsp

PRODUCT Diovan 80 mg, valsartan, 90 Tablets, Rx only, NOVARTIS, NDC 0078-0358-34, [NOTE: The recalled bottles with the printing error lack the “80 mg” and “90 Tablets” in green text on the label]
CODE Lots F0182, exp. OCT 2007; F0183, exp. NOV 2007; F0184, exp. NOV 2007; F0185, exp. NOV 2007; F0185 W1, exp. NOV 2007
RECALLING FIRM/MANUFACTURER Novartis Pharmaceuticals Corp., Suffern, NY
REASON Labeling: labels on a small quantity of bottles may lack the product strength and tablet count information.
VOLUME OF PRODUCT IN COMMERCE 239,568 bottles (total of 5 lots)
DISTRIBUTION Nationwide and PR

PRODUCT Ultane® (sevoflurane) Inhalation Anesthetic, 250mL bottles, Rx only, NDC 0074-4458-04
CODE Lot numbers: 34482DK, 34483DK and 34484DK
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, North Chicago , IL
Manufacturer: Hospira, Inc., Rocky Mount , NC
REASON Defective container; bottles may have pinholes which could cause product to leak or evaporate.
VOLUME OF PRODUCT IN COMMERCE 53,442 bottles
DISTRIBUTION Nationwide, PR, Jamaica , Bermuda , and the Bahamas

PRODUCT
a) Levothyroxine Sodium Tablets USP, 50 mcg (0.05mg), 100 count bottles, Rx only,
NDC 0781-5181-01\
b) Levothyroxine Sodium Tablets USP, 88 mcg (0.088mg), 100 count bottles, Rx only,
NDC 0781-5183-01
c) Levothyroxine Sodium Tablets USP, 100 mcg (0.1mg), 100 count bottles, Rx only,
NDC 0781-5184-01
CODE
a) Lot # 04T0971A Exp. Mar 06;
b) 03T4661A Exp 12/05, 03T6151A Exp 03/06, 03T6161A Exp 03/06, 03T6171A Exp 03/06,
04T1800 Exp 03/06, C0T0071A Exp 03/06 04T1821A Exp 03/06, 04T1841A Exp 03/06
04T1851A Exp 03/06;
c) 03T4191A Exp 02/06, 03T4161A Exp 02/06, 03T4211A Exp 02/06, 04T0500 Exp 03/06,
04T0750 Exp 03/06, 04T0760 Exp 03/06, C04T0041A Exp 03/06, 04T0831A Exp 03/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alara Pharmaceutical Corp, Caguas , PR,
Manufacturer: Mova Pharmaceutical Corp, Caguas , PR
REASON Subpotent; (21 month stability)
VOLUME OF PRODUCT IN COMMERCE 148,928 bottles
DISTRIBUTION Nationwide

PRODUCT Sufentanil Citrate U.S.P. C-II 500 mg CAS 60561-17-3
CODE Lot 315-05054-014, Expiration Date 03/31/06
RECALLING FIRM/MANUFACTURER Cody Laboratories, Inc., Cody , WY
REASON The level of acetone within sufentanil citrate was found to be out of specification.
VOLUME OF PRODUCT IN COMMERCE 17.9 grams
DISTRIBUTION Nationwide

PRODUCT Prenatal Optima Advance Tablets, 10 Tablets per 10 Blister Strips per 100 count package
CODE Lot numbers: 131518A exp 02/2006, 133208A exp 06/2006 and 133210A exp 05/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals, USA , Sellersville , PA
Manufacturer: Novopharm Limited Toronto, Canada
REASON Disintegration Failure
VOLUME OF PRODUCT IN COMMERCE 14,421 cartons of 100 tablets (10 Blister Strips of 10 Tablets per carton)
DISTRIBUTION Nationwide

PRODUCT Ranitidine Tablets USP, 150 mg. The product is sold in 1000, 500, and 60 count bottles, CODE Lot numbers 139432A exp 7/07, 139412A exp 7/07, and 139413A exp 7/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: TEVA Pharmaceuticals USA, Sellersville , PA
Manufacturer: Novopharm Ltd., Toronto , Canada
REASON Discoloration
VOLUME OF PRODUCT IN COMMERCE 84,485 bottles
DISTRIBUTION Nationwide

PRODUCT
a) Pramosone Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%), 3 gram
professional sample size metal tubes, 12 tubes, Rx only, NDC 0496-0716-33,
b) Analpram HC Cream 2.5% (hydrocortisone acetate 2.5% and pramoxine HCl 1%) Net
Wt. 1 oz tubes, Rx only, NDC 0496-0800-04,
CODE
a) Lot 04107A; Exp. 7/07;
b) Lot 04139A; Exp. 08/06
RECALLING FIRM/MANUFACTURER Ferndale Laboratories, Inc., Ferndale , MI
REASON Defective container; the metal tubes may have pinhole defects, which would result in a superpotent product.
VOLUME OF PRODUCT IN COMMERCE 194,383 tubes
DISTRIBUTION
Nationwide

WEEK ENDING MARCH 25

PRODUCT GenTeal Lubricant Eye Gel, (Hypromellose 0.3%), supplied in 3.5mL and 10mL tubes and 3.5 mL Physician sample tubes
CODE Lot # and Exp. date: 10 ml tubes: Z12468, 01/2006; Z12900, 04/2006; Z13161, 05/2006. 3.5 mL Z12912, 03/2006; Z13314, 06/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp., East Hanover, NJ
Manufacturer: Cardinal Health Manufacturing Services B.V., Humacao, PR,
REASON Non-Sterility
VOLUME OF PRODUCT IN COMMERCE 142,399 tubes
DISTRIBUTION Nationwide

PRODUCT ENBREL for Injection (etanercept), 25mg/vial, Multiple -use Vial with 1mL Diluent For reconstitution of Enbrel, supplied in a carton containing four dose trays, also as replacement component trays and replacement dose trays, For Subcutaneous Use Only, Rx only, NDC 58406-425-01
CODE Lot number's: D042015, D041993, D041996, D046583, D042020, D046582, D046585, D046584, D046591, D046594, & D046595;
Lot number: D045965 (Replacement Component Tray);
Lot number: D045966 (Replacement Dose Tray)
RECALLING FIRM/MANUFACTURER Amgen, Inc., Thousand Oaks, CA
REASON Lack of Assurance of Sterility; due to possible missing, detached or loose tip caps for the diluent syringe that accompanies Enbrel (etanercept) 25mg/vial.
VOLUME OF PRODUCT IN COMMERCE 827,529 BWDI syringes
DISTRIBUTION Nationwide

PRODUCT GenTeal Lubricant Eye Gel, (Hypromellose 0.3%), supplied in 3.5mL and 10mL tubes and 3.5 mL Physician sample tubes
CODE GenTeal Gel 3.5 mL tubes: Z12747, 01/2006; Z12748, 01/2006; Z12911, 03/2006; Z13193, 05/2006; Z13260, 06/2006; Z13316, 06/2006; Z13259, 06/2006; Z13368, 06/2006; Z13826, 11/2006; Z13748, 11/2006.
GenTeal Gel 10mL tubes: Z12469, 12/2005; Z12470, 01/2006; Z12896, 03/2006; Z12898, 03/2006; Z12897, 03/2006; Z12895, 03/2006; Z12804, 03/2006; Z12899, 04/2006; Z13163, 05/2006; Z13167, 05/2006; Z13110, 05/2006; Z13165, 05/2006; Z13160, 05/2006; Z13111, 05/2006; Z13164, 05/2006; Z13162, 05/2006; Z13320, 07/2006; Z13301, 07/2006; Z13337, 08/2006; Z13335, 08/2006; Z13328, 08/2006; Z13326, 08/2006; Z13324, 08/2006; Z13322, 08/2006; Z13568, 11/2006; Z13570, 11/2006; Z13571, 12/2006; Z13573, 12/2006; Z13646, 12/2006;
GenTeal Gel, 3.5 mL, Physican Samples: Z12390, 01/2006; Z12391, 01/2006; Z12914, 04/2006; Z13026, 04/2006; Z13179, 06/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp., East Hanover, NJ
Manufacturer: Cardinal Health Manufacturing Services B.V., Humacao, PR
REASON Lack of Assurance of Sterility
VOLUME OF PRODUCT IN COMMERCE 1,182,179 tubes
DISTRIBUTION Nationwide

PRODUCT Prednisolone, Oral Solution, USP, 15mg/5mL, 240 mL (0472-0250-08) and 480 mL(0472-0250-16), Rx only, NDC 0472-0250-08
CODE Lot Numbers, Expiration Date: 501414, 7/06; 501415, 7/06; 506462, 6/07; 506463, 6/07; 510505, 10/07; 510506, 10/07; 511530, 11/07; 511531, 11/07; 601548, 1/08; 601549, 1/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpharma, Elizabeth, NJ.
Manufacturer: VistaPharm, Inc., Largo, FL
REASON Impurities/Degradation: total related compounds exceed the regulatory specification of 2.0%.
VOLUME OF PRODUCT IN COMMERCE 23,508 bottles
DISTRIBUTION Nationwide