FEBRUARY 2002

WEEK ENDING FEBRUARY 2

PRODUCT GenTeal Lubricant Eye Drops, 0.3% Hydroxypropyl methylcellulose 0.845 FL.OZ. (25mL) bottles.

CODE Lot No. 96455.

RECALLING FIRM/MANUFACTURER Novartis Ophthalmics, Inc. Duluth, GA

REASON Non-Sterile-contamination with penicillum sp.

VOLUME OF PRODUCT IN COMMERCE 22,272 units.

DISTRIBUTION Nationwide.

PRODUCT A) Humalog Injection Kits, insulin lispro injection (rDNA origin), 3 ml disposable insulin delivery device,

B) Humacart 3/7 Kits, Humalog Pen, 3.0 mL disposable insulin delivery device (70% human insulin isophane suspension 30% human insulin injection (rDNA origin)) 100 units per mL.,

C) Humacart R Kits, Humalog Pen (pre-filled) disposable insulin delivery device.

CODE A) Humalog kits lot FF1E79J; B) Humacart 3/7 kits; lots FF1J79J and FF1J79N.Exp. 05/2003; C) Humacart R kits; lots FF1J71K and FFOV67A. Exp. 5/2003 and 9/2003.

RECALLING FIRM/MANUFACTURER Eli Lilly and Co., Indianapolis, IN

REASON Subpotency (Last dose may deliver less insulin than expected due to breakage of pen internal parts).

VOLUME OF PRODUCT IN COMMERCE Approx. 115,000 pens.

DISTRIBUTION Japan.

PRODUCT Anectine (succinylcholine chloride) Injection, 200 mg/10mL (20mg/mL),10 mL Multiple Dose vial, Rx only; Retrovir (zidovudine) IV Infusion, sterile, 10 mL/mL, 20 mL single use vial, Tray of 10 vials, Rx only

CODE Anectine Injection - Lot Number 0L2080; Retrovir IV Infusion - Lot Number 9K2300.

RECALLING FIRM/MANUFACTURER Recalling Firm: GlaxoSmithKline Zebulon, NC

Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC.

REASON Lack of assurance of sterility (glassware may exhibit cracks).

VOLUME OF PRODUCT IN COMMERCE Anectine - 8,162 units and Retrovir - 1,062 units.

DISTRIBUTION Nationwide.

WEEK ENDING FEBRUARY 9

PRODUCT M.V.I. Pediatric, multi-vitamins for infusion, For Intravenous Infusion Only, Single Dose Vial, sterile, Rx only

CODE OK1908.

RECALLING FIRM/MANUFACTURER Recalling Firm: NeoSan Pharmaceuticals, Wilmington, NC

Manufacturer: DSM Catalytica, Greenville, NC.

REASON Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE 9,334 units.

DISTRIBUTION Nationwide.

PRODUCT 1) Otrivin, Pediatric Nasal Drops (0.05% xylometazoline HCl, USP) Nasal Decongestant, .83 fl oz (25ml) bottle;

2) Otrivin, Nasal Drops ( 0.1% xylometazoline HCl, USP) Nasal Decongestant, .83 fl oz (25ml) bottle.

CODE Pediatric:

Lot Exp.

LAH001 6/02

LAH006 10/02

LAH008 7/03

LAH011 12/03

LAH015 8/04

LAH019 5/05

Adult:

LAE013A 4/02

LAE016 7/02

LAE027 3/03

LAE039 7/03

LAE071 7/04

LAE073 9/04

LAE090 5/05.

RECALLING FIRM/MANUFACTURER Recalling Firm: Novartis Consumer Health Inc., Summit, NJ

Manufacturer: Patheon Inc., Mississauga, Ontario, Canada.

REASON Container closure deficiencies leading to leakage/evaporation and possible higher concentrations of the active ingredient.

VOLUME OF PRODUCT IN COMMERCE 231,260 bottles.

DISTRIBUTION Nationwide.

PRODUCT Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution USP, Sterile, 10mL with sterilized dropper, Rx only. The product is labeled as Dist. by: Falcon Pharmaceuticals, Ltd., Fort Worth, TX.

CODE Codes:

Lot Number Expiration

0C1782 7/2002

0C1783 7/2002

0C1784 7/2002

0C1785 7/2002

0C1786 8/2002

0C1787 8/2002

0C1788 8/2002

0C1789 8/2002

0F2139 10/2002.

RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN

Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC.

REASON Lack of assurance of sterility (glassware defects).

VOLUME OF PRODUCT IN COMMERCE 410,154 units.

DISTRIBUTION TX, NV and MD.

PRODUCT Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension USP, Sterile, 10 mL with Sterilized Dropper, Rx only.

The product is labeled as distributed by Falcon Pharmaceuticals, Ltd., Forth Worth, TX.

CODE Codes:

Lot Number Expiration

0J1494 4/2003

0C1643 4/2002

0C1644 4/2002

0C1775 4/2002

0C1776 4/2002

0C1777 5/2002

0C1779 5/2002

0C1780 5/2002

0C1781 5/2002

0D1790 5/2002

0F2249 7/2002

0F2139 7/2002

0G2335 10/2002

0H2488 10/2002

0I1410 3/2003

0I1409 2/2003

0I1408 2/2003

1B1419 5/2003

1B1418 5/2003

1B1456 6/2003

1B1309 4/2003

0I1411 2/2003.

RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN

Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC.

REASON Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE 1,164,571 units.

DISTRIBUTION TX, NV and MD.

PRODUCT Pediotic Suspension Sterile, 7.5mL with sterilized dropper, (Neomycin and Polymyxin B Sulfates and Hydrocoritsone otic

Suspension, USP) For use in ears only, Rx only.

CODE Lots: 0F2247 (Exp 8/2002), 0F2248 (Exp 8/2002/), 0C1661 (Exp 8/2002/), 0G2420 (Exp 8/2002), and 0I1412 (Exp 11/2002).

RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN

Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC.

REASON Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE 110,663 units.

DISTRIBUTION Nationwide.

PRODUCT Cortisporin Otic Suspension Sterile (Neomycin and Polymyxin B Sulfates and Hydrocortisone Suspension), 10mL with sterilized

dropper, For use in ears only, Rx only.

CODE Lot 0B1436 (Expiration 3/2002) and 0I1407 (Expiration (11/2002).

RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN

Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC.

REASON Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE 109,559 units.

DISTRIBUTION Nationwide.

PRODUCT Cortisporin Otic Solution Sterile(neomycin and polymyxin B sufates, and hydrocortisone otic solution,USP), 10mL with sterilized dropper, Rx only

CODE 0D1791 (Expiration 8/2002).

RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN

Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC.

REASON Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE 42,433 units.

DISTRIBUTION Nationwide.

PRODUCT Cortisporin Opthalmic Suspension Sterile (Neomycin and Polymyxin B Sulfates and Hydrocortisone Opthalmic Suspension,USP), 7.5 mL Drop Dose, Rx only.

CODE Codes:

Lot Number Expiration

0A1319 1/2002

0A1320 1/2002

0A1321 1/2002

0A1322 1/2002

0A1323 2/2002

0A1324 2/2002

0A1326 4/2002

0A1327 4/2002

0B1437 4/2002

0D1923 6/2002

0D1924 6/2002

0D1925 6/2002

0E2048 6/2002

0E2049 6/2002

0E2051 6/2002

9J1934 12/2001

9J1935 12/2001

9J1936 12/2001

0G2333 8/2002

0G2334 8/2002

0G2415 9/2002

0I1399 10/2002

0I1400 11/2002

0I1401 11/2002

0I1402 11/2002

0I1403 11/2002

0I1404 11/2002

0I1405 11/2002

0I1406 1/2003

0J1619 1/2003

0J1620 2/2003

0J1622 4/2003

RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN

Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC

REASON Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE 693,718 units.

DISTRIBUTION Nationwide.

PRODUCT Neosporin G.U. Irrigant Sterile (Neomycin Sulfate and Polymixin B Sulfate solution for irrigation), Not for Injection, 20mL Multiple Dose Vial, Rx only.

CODE Lot 9J2127, Expiration 11/2003.

RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN

Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC.

REASON Lack of assurance of sterility (glassware defects).

VOLUME OF PRODUCT IN COMMERCE 13,223 units.

DISTRIBUTION Nationwide.

PRODUCT Septra I.V. Infusion Sterile, 20 mL Multiple dose vial, (trimethoprim and sulfamethoxazole 16mg/80mg), Rx only

CODE Lot 0D1933, Expiration 6/2003.

RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN

Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC.

REASON Lack of assurance of sterility (glassware defects).

VOLUME OF PRODUCT IN COMMERCE 1427 units.

DISTRIBUTION Nationwide.

PRODUCT Hydralazine Hydrochloride Injection, USP, 20 mg/mL, For IM or IV use, 1 mL single dose vial. This product is packed under two brand labels. Gensia Sicor and NovaPlus.

CODE The following lots are affected: 00B119, 00C116, 00H113, 00J105, 00K111, 00K118, 00K128, 01A125, 01D113, 01D118, 01K107.

RECALLING FIRM/MANUFACTURER Gensia Sicor Pharmaceuticals Inc., Irvine, CA

REASON Particulate matter specification failure (visual).

VOLUME OF PRODUCT IN COMMERCE 1,665,200 vials.

DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT Canasa, Mesalamine Suppositories, 500 mg, 30 suppository unit carton, For Rectal Use Only, Rx only.

CODE 1C057 and 1C058.

RECALLING FIRM/MANUFACTURER Recalling Firm: Scandipharm, Inc., Birmingham, AL

Manufacturer: Axcan Pharma, Quebec, CA

REASON Dissolution Failure (6 month stability station).

VOLUME OF PRODUCT IN COMMERCE 3220 boxes of 30 units.

DISTRIBUTION Nationwide.

PRODUCT Hydrocodone Bitartrate 2.5 mg and Acetaminophen 500 mg Tablets, USP, 100 tablet bottles under the Vintage and Qualitest labels

CODE 063040A and 063040B.

RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals Inc., Charlotte, NC

REASON Sub-potency (stability).

VOLUME OF PRODUCT IN COMMERCE 2,924 bottles.

DISTRIBUTION AL.

PRODUCT Pain Relieving Rub, Greaseless, Stainless Analgesic Cream, (Menthol 10%, Methyl Salicylate 15%), 4 oz net weight tube.

This is a white, smooth homogeneous cream that contains 10% (w/w) Menthol and 15% Methyl Salicylate as its active ingredients.

The recalled lots, 0045-3 and 0095-3, were packaged into one of the four following PVC tubes:

1) G & W generic tube labeled in part "Greaseless / Stainless *** Pain relieving rub *** Analgesic Cream *** For Muscle Aches and

Arthritis Pain"

2) HY-TOP tube labeled in part "NDC 61795-28304 *** Penetrating *** Muscle Rub *** Greaseless / Stainless Analgesic Cream"

3) Shop Rite tube labeled in part "Greaseless / Stainless ANALGESIC CREAM *** Pain relieveing rub *** For muscle aches and

arthritis pain"

4) H-E-B Pharmacy tube labeled in part "Muscle Rub *** Greaseless Pain Relieving Cream *** For Muscle Aches & Arthritis Pain"

The recalled lots were packaged into one of the five following boxes:

1) G & W box labeled in part "Greaseless/Stainless Analgesic Cream *** Pain relieving rub *** For Muscle Aches and Arthritis

Pain *** Arthritis, Backaches, Muscle Aches". The Universal Product Code (UPC) number on the bottom of the box is 0713-0283-04

2) HY-TOP box labeled in part "NDC 61795-28304 *** Penetrating *** Muscle Rub *** Greaseless / Stainless Analgesic Cream". The

UPC number on the bottom of the box is 50700-05861 .

3) Shop Rite box labeled in part "Greaseless / Stainless Analgesic Cream *** Pain relieving rub *** for muscle aches and arthritis pain". The UPC number on the bottom of the box is 41190-21816

.4) H-E-B Pharmacy box labeled in part "Muscle Rub *** Greaseless Pain Relieving Cream *** For Muscle Aches & Arthritis Pain". The UPC number on the bottom of the box is 41220-52909 .

5) 1st Choice Box labeled in part "Greaseless/Stainless Analgesic Cream *** Pain relieving rub *** For muscle aches and arthritis pain". The UPC number on the bottom of the box is 39131-28304

Each tube was placed in its corresponding box (ie. HY-TOP tube in the HY-TOP box and H-E-B tube in the H-E-B box) except that the G & W

generic tube was placed in both the G & W and 1st Choice box.

CODE Lot Numbers: 0045-3 Exp. 3/2002; 0095-3 Exp. 4/2002.

RECALLING FIRM/MANUFACTURER G&W Laboratories Inc., South Plainfield, NJ

REASON Subpotent: active ingredient Methyl Salicylate.

VOLUME OF PRODUCT IN COMMERCE Lot 0045-3 -- 7632 pieces; Lot 0095-3 -- 11,136 pieces.

DISTRIBUTION Nationwide.

WEEK ENDING FEBRUARY 16

PRODUCT Various tablet and capsule dosage form drug products, repackaged into plastic amber pharmacy vials and unit dose blister packs of varying sizes/counts, labeled with brand or generic names, strength, lot number, expiration date, manufacturer, National Drug Codes (NDC) and name of repacker of the products (PDS).

PRODUCT

ACETAMINOPHEN 325 mg tablets

AMOXICILLIN 500 mg capsules

ALLEGRA-D (FEXOFENADINE/PSEUDOEPHEDRINE HCL)

60mg/120mg tablets

ASPIRIN EC 325 mg tablets

ASPIRIN EC 81 mg tablets

ATENOLOL 50 mg tablets

BAYCOL (CERIVASTATIN SOD) 0.3 mg tablets

BAYCOL (CERIVASTATIN SODIUM) 0.4 mg tablets

BENZONATATE 100mg capsules

CALCIUM 500 mg (OYSCO) tablets

CALCIUM 500 mg (OYST-CAL) tablets

CARDURA (DOXAZOSIN MESYLATE) 2 mg tablets

CELEXA (CITALOPRAM HBr) 20 mg tablets

CEPHALEXIN 250 mg capsules

CIPROFLOXACIN HCL 500 mg tablets

CLARITIN (Loratidine) 10 mg tablets

CYCLOBENZAPRINE HCL 10 mg tablets

DE-CONGESTINE (CHLORPHEN. MALEATE 8 mg/PSEUDOEPHEDRINE 120mg) capsules

DECONSAL II (PSEUDOEPHEDRINE AND GUAIFENESIN) 60 mg/600mg tablets

DIPHENHYDRAMINE HCL 25 mg capsules

DOCUSATE SODIUM 100 mg capsules

DOCUSATE SODIUM 100 mg gel capsules

DOXYCYCLINE 100 mg capsules

ERYTHROMYCIN 250 mg tablets

FOLIC ACID 1 mg tablets

FUROSEMIDE 20 mg tablets

FUROSEMIDE 40 mg tablets

GLUCOPHAGE (METFORMIN HCL) 500 mg tablets

GUAIFENESIN LA 600 mg capsules

GUAIFENEX PSE 600 mg/60mg capsules

HYDROCHLOROTHIAZIDE 25 mg capsules

HYDROXYZINE HCL 25 mg tablets

HYTRIN (TERAZOCIN) 2 mg capsules

HYTRIN (TERAZOCIN) 5 mg capsules

IBUPROFEN 400 mg tablets

IBUPROFEN (MOTRIN) 800 mg tablets

ISONIAZID 300 mg tablets

K-DUR (KCl) 20 mEq tablets

CEPHALEXIN (KEFLEX) 250 mg capsules

KLOR-CON (KCl) 10mEq (750 mg) tablets

LEVAQUIN (LEVOFLOXACIN) 500 mg tablets

LEVOTHROID .1 mg tablets

MACROBID (NITROFURANTOIN) 100 mg capsules

METHOCARBAMOL 500 mg tablets

METRONIDAZOLE 250 mg tablets

MOTRIN (IBUPROFEN) 600 mg tablets

MULTI-VITAMINS Tablets

NAPROSYN 500 mg tablets

NAPROXEN 500 mg tablets

NORVASC (Amlodipine Besylate) 5 mg tablets

NORVASC (Amlodipine Besylate) 10mg tablets

PHENAZOPYRIDINE HCL 100 mg tablets

PLENDIL (FELODIPINE) 5 mg tablets

POTASSIUM CHLORIDE 10mEq capsules

PREMARIN .3 mg tablets

PREMARIN .625 mg tablets

PRILOSEC (OMEPRAZOLE) 20 mg capsules

PROMETHAZINE 25 mg tablets

PROVERA 2.5 mg tablets

PROZAC (FLUOXETINE) 20 mg capsules

PSEUDOEPHEDRINE HCL 30 mg tablets

PSEUDOEPHEDRINE HCL 60 mg tablets

Q-BID LA (GUAIFENESIN LA) 600 mg tablets

RANITIDINE 150 mg tablets

SULFAMETHOXAZOLE/TRIMETHOPRIM 800/160 MG tablets

SYNTHROID (LEVOTHYROXINE) 0.05 mg tablets

SYNTHROID (LEVOTHYROXINE) 0.075 mg tablets

SYNTHROID (LEVOTHYROXINE) 0.1 mg tablets

SYNTHROID (LEVOTHYROXINE) 0.125 mg tablets

TRIAMTERENE AND HYDRO-CHLORTHIAZIDE (MAXIDE) 75 mg/50 mg tablets

TRIMOX (AMOXICILLIN) 250 mg tablets

TYLENOL 325 mg tablets

VIAGRA 100 mg tablets

VITAMIN E 400 mg SOFTGEL capsules

VERAPAMIL 240 mg tablets

ZESTRIL (LISINOPRIL) 5 mg tablets

ZESTRIL (LISINOPRIL) 10 mg tablets

ZESTRIL (LISINOPRIL) 20 mg tablets

ZESTRIL (LISINOPRIL) 40 mg tablets

ZOCOR (SIMVASTATIN) 10 mg tablets

Z0COR (SIMVASTATIN) 20 mg tablets

ZOCOR (SIMVASTATIN) 40 mg tablets

ZOLOFT (SERTRALINE) 100 mg tablets

ZYRTEC 10 mg tablets

CODE All expiration dates for the products distributed by the repacker since startup of firm's operations in Aug 2000 through exp. date Nov

2002. Expiration dates are printed on the label applied to vials and blister packs and determined by the repacker based on one year from date

of repack.

RECALLING FIRM/MANUFACTURER Pharmaceutical Distribution Services, Laurel, MD

REASON Contamination: Failure to test for penicillin in non-penicillin products due to potential cross-contamination operations

VOLUME OF PRODUCT IN COMMERCE Unknown.

DISTRIBUTION MD, DC and VA.

PRODUCT a) Marinol (Dronabinol) Capsules, 2.5 mg, bottles of 60, Rx only, b) Marinol (Dronabinol) Capsules, 10 mg, bottles of 60, Rx only,

CODE a) 2.5 mg. capsules, NDC #0051-0021-21 Lots 11110010A and 11110011A, both expire 10/03; b) 10 mg. capsules, NDC #0051-0023-21 Lot 11110012A, expires 10/03.

RECALLING FIRM/MANUFACTURER Recalling Firm: Unimed Pharmaceuticals, Inc. Deerfield, IL

Manufacturer: Banner Pharmacaps, Inc. Chatsworth, CA.

REASON Container defects-some bottles are missing their inner foam seal.

VOLUME OF PRODUCT IN COMMERCE 8,240 bottles of 2.5 mg, 456 bottles of 10 mg.

DISTRIBUTION Nationwide.

WEEK ENDING FEBRUARY 23

PRODUCT a) Lunelle Monthly Contraceptive Injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension), 25 mg/5mg., 0.5 ml vial and 0.5 mL vial as physician sample; b) Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable suspension) 150 mg/ml, 1 ml. vials, For Export.

CODE a) Lot 65HHX; exp. 10/2003 Lot 76HHH; exp. 10/2003; b) Lots 49HHC, 50HHC and 71HHH; exp. 10/2005.

RECALLING FIRM/MANUFACTURER Pharmacia Corporation, Kalamazoo, MI

REASON Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE Approx. 400,000 units.

DISTRIBUTION Nationwide.

PRODUCT Tegretol Tablets, (Carbamazepine, USP), 200 mg.; 100 tablet Bottles.

CODE Product #0163-1, lot numbers 9243162 and 9245086.

RECALLING FIRM/MANUFACTURER Recalling Firm: Allscripts Healthcare Solutions Libertyville, IL

Manufacturer: Novartis Pharmaceutical Company East Hanover, NJ.

REASON Dissolution failure (by manufacturer)

VOLUME OF PRODUCT IN COMMERCE 5 bottles.

DISTRIBUTION IA and HI.

PRODUCT a) Metoclopramide Oral Solution, USP, 5 mg/5 mL dose cups. b) Metoclopramide Oral Solution, USP, 10 mg/10 mL dose cups.

CODE a) 5 mL unit dose cups: lots 101030, 102015; b) 10 mL unit dose cups: lots 101028, 101029, 101038, 102002, 102016.

RECALLING FIRM/MANUFACTURER Recalling Firm: Unit Dose Laboratories Inc., Rockford, IL

Manufacturer: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL.

REASON Subpotency (at manufacturing firm).

VOLUME OF PRODUCT IN COMMERCE a) 3620 cases of 5 mL cups; b) 8448 cases of 10 mL cups.

DISTRIBUTION Nationwide.