AUGUST 2000

JANUARY 2002

WEEK ENDING JANUARY 19

PRODUCT CVS brand Infants' gas relief drops (simethicone/antiflatulent) 0.3 mL contains 20 mg of Simethicone, 1 oz bottle,

CODE Lot 1251 Exp. 4/2003.

RECALLING FIRM/MANUFACTURER Accumed Inc., Lawrenceville, NJ

REASON Microbial test specification failure - Pseudomonas aeruginosa.

VOLUME OF PRODUCT IN COMMERCE 12,210 bottles.

DISTRIBUTION Nationwide.

PRODUCT Carbamazepine Tablets, Tegretol brand, 200 mg, in bottles of 100 Tablets and 1000 Tablets

CODE Lot/code/expiration date: 124B0093 (bottles of 100s); 174D4344 (bottles of 1000s); 234E9126 (bottles of 1000s) .

RECALLING FIRM/MANUFACTURER Novartis Pharmaceuticals Corp., Suffern, NY

REASON Dissolution failure (at stability testing).

VOLUME OF PRODUCT IN COMMERCE 44, 212 bottles: lot 124B0093 - 36,665 bottles; lot 174D4344 - 3717 bottles; lot 234E9126 - 3830 bottles.

DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT Anti-Aging Wrap solution, 8 oz., 32 oz. and 36 oz. plastic bottles. (conditioned water plus a proprietary blend of sodium magnesium and potassium salts, boron and other naturally occurring trace elements and herbal essences)

CODE All Codes labeled as "Anti-Aging Wrap" that were distributed from 10/1/00 through 10/1/01 including lot #'s AA439090500 and AA110101CS.

RECALLING FIRM/MANUFACTURER Recalling Firm: VMM Enterprises, Inc. Clearwater, FL

Manufacturer: Pyramid Consulting and Investiment Co., Inc. Clearwater, FL.

REASON Microbial Contamination; product is contaminated with Pseudomonas aeruginosa.

VOLUME OF PRODUCT IN COMMERCE Unknown

DISTRIBUTION Nationwide

PRODUCT

Tazicef (Ceftazidime for Injection) 1 gram 15,20 & 100 mL vial;

Tazicef (Ceftazidime for Injection) 2 gram 21,60 & 100 mL vial;

Tazicef (Ceftazidime for Injection) 6 gram 100 mL vial.

Tazidime (Ceftazidime for Injection,USP) 1 gram 15,20 & 100 mL vial;

Tazidime (Ceftazidime for Injection,USP) 2 gram 21,60 & 100 mL vial;

Tazidime (Ceftazidime for Injection,USP) 6 gram 100 mL vial.

CODE Tazicef & Tazidime:

Abbott Product Numbers: K5082-16, K5083-11, K5084-11, K5085-11, and K-5086-11 and

Eli Lilly Product Numbers: VL72310, VL72340, VL72380, VL72390, and VL72410

Tazicef ADD-Vantage & Tazidime:

Abbott Product Numbers: K5090-16 and K5091-11

Eli Lilly Product Numbers: VL72900 and VL72910

Abbott Product #K5082-04-16, Lots: 59004DA exp. Nov-01, 59011DA exp. Nov-01, 59012DA exp. Nov-01, 59016DA exp. Nov-01,

61017DA exp. Jan-02, 61018DA exp. Jan-02, 62001DA exp. Feb-02, 68012DA exp. Aug-02, 69007DA exp. Sep-02, 71010DA exp. Nov-02,

72001DA exp. Dec-02, and 72006DA exp. Dec-02.

Abbott Product #K5083-04-01, Lots: 61008DA exp. Jan-02 and 70003DA exp. Oct-02.

Abbott Product #K5084-04-01, Lots: 59013DA exp. Nov-01, 59014DA exp. Nov-01, 59015DA exp. Nov-01, 61005DA exp. Jan-02,

64005DA exp. Apr-02, 71011DA exp. Nov-02, and 76029DA exp. Apr-03.

Abbott Product #K5085-04-01, Lot: 61009DA exp. Jan-02

Abbott Product #K5086-04-01, Lots: 58008DA exp. Oct-01, 60002DA exp. Dec-01, 60003DA exp. Dec-01, 71009DA exp. Nov-02,

72007DA exp. Dec-02, 73020DA exp. Jan-03, and 77007DA exp. May-03.

Abbott Product #K5090-04-01, Lots: 58005DA exp. Oct-01, 58006DA exp. Oct-01, 72003DA exp. Dec-02, and 75020DA exp. Mar-03.

Abbott Product #K5091-04-11, Lots: 58007DA exp. Oct-01, 61003DA exp. Jan-02, and 61004DA exp. Jan-02.

Eli Lilly Lots: 8010T90 exp. 3/31/02, 8020T90 exp. 4/30/02, 8029T90 exp. 9/30/01, 8030T90 exp. 4/30/02, 8039T90 exp. 9/30/01, 8040T90 exp. 5/31/02, 8049T90 exp. 9/30/01, 8050T90 exp. 5/31/02, 8059T90 exp. 10/31/01, 8069T90 exp. 10/31/01, 8079T90 exp. 10/31/01, 8089T90 exp. 10/31/01, 8099T90 exp. 10/31/01, 8109T90 exp. 11/30/01, 8129T90 exp. 12/31/01, and 8139T90 exp. 12/31/01.

Eli Lilly Lot: 4019T83 exp. 12/31/01

Eli Lilly Lots: 1010T82 exp. 2/28/02, 1011T82 exp. 1/31/03, 1020T82 exp. 2/28/02, 1029T82 exp. 11/30/01, 1030T82 exp. 2/28/02, 1039T82 exp. 11/30/01, 1040T82 exp. 4/30/02, 1050T82 exp. 7/31/02, 1060T82 exp. 11/30/02, 1070T82 exp. 11/30/02, and 1080T82 exp. 12/31/02.

Eli Lilly Lots: 9010T91 exp. 3/31/02, 9019T91 exp. 10/31/01, 9020T91 exp. 3/31/02, 9029T91 exp. 11/30/01, 9030T91 exp. 4/30/02, 9039T91 exp. 11/30/01, and 9040T91 exp. 4/30/02.

Eli Lilly Lot:5019T85 exp. 12/31/01

Eli Lilly Lots: 2010T84 exp. 2/28/02, 2019T84 exp. 11/30/01, 2020T84 exp. 3/31/02, 2030T84 exp. 4/30/02, 2040T84 exp. 5/31/02, and 2050T84 exp. 11/30/02.

Eli Lilly Lots: 6010T86 exp. 2/28/02, 6011T86 exp. 1/31/03, 6020T86 exp. 4/30/02, 6029T86 exp. 10/31/01, 6039T86 exp. 10/31/01, 6049T86 exp. 11/30/01, 6059T86 exp. 11/30/01, and 6069T86 exp. 11/30/01.

RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories Abbott Park, IL, (Abbott, Eli Lilly and GlaxoSmithKline)

Manufacturer: GlaxoSmithKline Conshohocken, PA.

REASON Lack of assurance of sterility

VOLUME OF PRODUCT IN COMMERCE 1124637 units

DISTRIBUTION Nationwide

PRODUCT Poly-Tussin Syrup Sugar Free/Alcohol Free Sorbitol Free/Sodium Free 16 oz bottles, Rx Only Each 5 mL (one teaspoonful)for oral administration contains: Hydrocodone Bitartrate 5 mg, Phenylephrine Hydrochloride 5 mg, and Chlorpheniramine Maleate 2 mg.

CODE Lot # 1E04, exp 05/03

RECALLING FIRM/MANUFACTURER Pharmacon Labs, Inc. Tampa, FL

REASON Superpotentcy : Hydrocodone Bitartrate and Phenylephrine HCl.

VOLUME OF PRODUCT IN COMMERCE 1,313 16 oz bottles.

DISTRIBUTION KY

PRODUCT Triple Paste, Medicated Oinment, Zinc Oxide 11.6%, 2 oz (56.7g); 1 lb. (454 g) ; and Physician samples (11.5 g)

CODE 2 oz size Lots: 102101 exp. 10/04 and 107011 exp. 11/04

1 lb size Lots: 102101 exp. 10/04, 107011 exp. 11/04, and 106011 exp. 11/04 sample size Lots: 102101 exp. 10/04

RECALLING FIRM/MANUFACTURER Recalling Firm: Summer Laboratories Inc Collegeville, PA

Manufacturer: EMS Fort Washington, PA

REASON Misbranding : Product used as labeled may cause skin irritations

VOLUME OF PRODUCT IN COMMERCE 25687 units - 7230 of 2oz, 2857 of 1lb, & 15600 sample tubes

DISTRIBUTION Nationwide (except Alaska)

PRODUCT Levothroid Tablets, Forest Brand (levothyroxine sodium tablets, USP), 25 mcg., packaged in 100-tablet bottles, Rx only

CODE Lot #120011, Exp. 12/02; Lot #120013, Exp. 12/02

RECALLING FIRM/MANUFACTURER

Recalling Firm: Forest Pharmaceuticals, Inc., St. Louis, MO Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, OH

REASON Subpotent- prior to labeled expiration date

VOLUME OF PRODUCT IN COMMERCE Lot 120011 - 14,447/100-tab. btls; Lot 120013 - 14,607/100-tab. btls

DISTRIBUTION Nationwide

PRODUCT a) Respond First Aid Antiseptic Spray, 3 fl. oz, Lidocaine 2.5%, Benzalkonium Chloride 0.14%,;

b) Respond Burn Relief with Aloe Vera Antiseptic/Anesthetic Spray, 3 oz., Benzocaine 5% and Benzalkonium chloride 0.14%,.

CODE Respond Burn Spray, Lot # 0011037; Respond Antiseptic Spray, Lot # 0003065.

RECALLING FIRM/MANUFACTURER Recalling Firm: Respond Industries, Inc., Arvada, CO

Manufacturer: York Pharmaceuticals, Kansas City, KS

REASON Potency: Super-potent Benzocaine in burn spray, Sub-potent Lidocaine in antiseptic spray.

VOLUME OF PRODUCT IN COMMERCE 244 cases.

DISTRIBUTION Nationwide.

PRODUCT a) Generlac Solution, (Lactulose Solution, USP), 10 g/15 mL, 16 oz., bottles, product code 8038, packaged under the MGP label,

Rx only;

b) Hydroxyzine Hydrochloride Syrup, USP, 10 mg/5 mL, 4 oz. & 16 oz. bottles, product code 8150, Rx only,;

Packaged under the following labels:

i) MGP label, 4 oz. & 16 oz.,

ii) Major Pharmaceuticals label, 16 oz.,

iii) URL label, 16 oz.,

c) Metoclopramide Oral Solution, USP, 5 mg/5 mL, 16 oz. bottles, product code 7622, packaged under the MGP label,

d) Clindamycin Phosphate Topical Solution, USP 1%, 1 oz. & 2 oz. bottles, product code 8693, Rx Only, packaged under the MGP label,

1 oz. and 2 oz.

CODE a) Generlac Solution - lot 23562; b) Hydroxyzine HCl Syrup - lot 23413A, 23413F; c) Metoclopramide Oral Solution - lot 23576;

d) Clindamycin Phosphate Topical Solution - lot 23408A, 23408C, 23408E.

RECALLING FIRM/MANUFACTURER Morton Grove Pharmaceuticals, Inc. Morton Grove, IL

REASON Subpotency for Generlac, Hydroxyzine HCL, and Metoclopramide; Degradent failure for Clindamycin.

VOLUME OF PRODUCT IN COMMERCE

a) 15120 btls;

b) 6912-4 oz & 36238-16 oz btls;

c) 38588 btls;

d) 6123-1 oz & 5700-2 oz btls.

DISTRIBUTION Nationwide.

PRODUCT AK-CIDE brand of Prednisolone Acetate, USP and Sulfacetamide Sodium, USP, Ophthalmic Ointment-Sterile, 3.5 g tube. Each gram of ointment contains 100 mg/g of Sulfacetamide sodium USP and 5 mg/g of Prednisolone acetate USP.

CODE Lot 9-AH-1, exp. date March 2002; Lot 9-AH-2, exp. date March 2002.

RECALLING FIRM/MANUFACTURER Schering-Plough Products, Inc., Manati, Puerto Rico

REASON Subpotency for Sodium Sulfacetamide component (stability).

VOLUME OF PRODUCT IN COMMERCE 48,000 units.

DISTRIBUTION IL.

PRODUCT Infants' Simethicone Drops, Simethicone, 20 mg in each 0.3 mL, 1 fluid ounce(30mL) bottles.

This product was distributed under 52 brand labels,

1) Guardian brand Infant's Wind Relief With Simethicone.

2) Albertson's brand, Discontinued.

3) Sav-on Osco by Albertson's brand Infants' Simethicone Drops

4) Sav-on Osco by Albertson's brand Infants' Simethicone Drops, Non-Staining Formula.

5) American Fare brand Infants' Gas Symptom Relief Simethicone Drops.

6) Ameripharm brand Infants' Baby Gaz Simethicone Anti-Gas Drops.

7) Brite-Life brand Infants' Gas Relief Drops Simethicone Anti-Gas.

8) Dominick's brand Infants' Simethicone Drops.

9) Drug Emporium brand Infants' Simethicone Drops.

10) Elect Health brand Infants' Gas Relief Drops Simethicone, Non-Staining Formula.

11) Equate brand Infants' Gas Relief Drops Simethicone, Non-Staining Formula.

12) Finast brand Infants' Gas Relief Drops Simethicone, Non-Staining Formula.

13) Food Lion brand Infants' Simethicone Drops.

14) Full Value brand.

15) Giant Eagle brand Infants' Gas Relief Drops Simethicone.

16) Good Neighbor Pharmacy brand Infants' Gas Relief Drops, Simethicone.

17) Good Sense brand Infants' Simethicone Drops, Perrigo.

18) Good Sense brand Infants' Simethicone Drops, Non-Staining Formula, Perrigo.

19) H.E.B. Pharmacy brand Infants' Simethicone Drops.

20) Health Mart Pharmacies brand Simethicone Gas Relief Infants' Drops.

21) Kaiser Permanente brand Infants' Simethicone Drops, Kaiser Foundation Hospitals, Livermore, CA.

22) Kn'K Preferred brand Infants' Simethicone Drops, Dist. By Kash n' Karry, Tampa, FL.

23) Kerr Drug brand Infants' Simethicone Drops.

24) Kroger brand Infants' Simethicone Drops, Non-Staining Formula

25) Leader brand Infants' Simethicone Drops, Dist. by Cardinal Health, Inc., Dublin, OH.

26) Longs brand Infants' Simethicone Drops, Dist. by Longs Drug Stores, Walnut Creek, CA.

27) Longs brand Infants' Simethicone Drops Non-Staining Formula,

28) Marquee brand Infants' Simethicone Drops.

29) May's Drug brand Infants' Simethicone Drops Non-Staining Formula.

30) Meijer brand Infants' Simethicone Drops Non-Staining Formula,

31) Osco brand. Discontinued.

32) Osco brand. Discontinued.

33) Perfect Choice brand Infants' Simethicone Drops

34) Perfect Choice brand Infants' Simethicone Drops Non-Staining Formula, Cincinnati, OH.

35) Phar Mor brand Infants' Simethicone Drops.

36) Phar Mor brand Infants' Simethicone Drops Non-Staining Formula.

37) Safeway brand Infants' Simethicone Drops.

38) Sav-On brand. Discontinued.

39) Sav-On brand. Discontinued.

40) Shop Rite brand Infants' Simethicone Drops,

41) Shopko brand. Discontinued.

42) Stater Bros. Markets brand Infants' Simethicone Drops,

43) Stop & Shop brand Infants' Gas Relief Drops Non-Staining Formula.

44) Swan brand Infants' Simethicone Drops, Perrigo.

45) Target brand Infants' Gas Relief Non-Staining Formula,

46) Today's Health brand Infants' Simethicone Drops,

47) Top Care Infants' Simethicone Drops.

48) Valu Rite brand Simethicone Gas Relief Infants' Drops,

49) Valu Rite brand Simethicone Gas Relief Infants' Drops Non-Staining Formula.

50) Vons brand Infants' Simethicone Drops.

51) Walgreens brand Infants' Gas Relief Drops,

52) Walgreens brand Infants' Gas Relief Drops Non-Staining Formula.

53) Western Family brand Simethicone Infants' Gas Relief Drops,

54) Medic brand Infants' Simethicone Drops.

CODE All lots within expiry.

RECALLING FIRM/MANUFACTURER Perrigo, Allegan, MI

REASON Subpotent for simethicone.

VOLUME OF PRODUCT IN COMMERCE 234,473 bottles

DISTRIBUTION Nationwide, Vietnam and the Philippines.

PRODUCT Premarin tablets, 1.25mg (Conjugated Estrogens Tablets, USP), Rx, 100 count tablets.

CODE Lot #03138, Exp 09/03.

RECALLING FIRM/MANUFACTURER Recalling Firm: Rx Pak, Division of McKesson HBOC Memphis, TN

Manufacturer: Ayerst Laboratories, Rouses Point, NY.

REASON Dissolution failure by manufacturer.

VOLUME OF PRODUCT IN COMMERCE 41, 545 100 count bottles.

DISTRIBUTION Nationwide.

PRODUCT Ketoprofen Extended-Release Capsules, 200 mg., 100 capsules bottles labeled as Mfd. for: Schein Pharmaceutical, Inc., Mfd by: Elan Pharma Ltd. The product is an Rx only.

CODE Lot P0K0252.

RECALLING FIRM/MANUFACTURER Recalling Firm: Elan Pharmaceuticals Research Corp. Gainesville, GA

Manufacturer: Elan Pharma Ltd. County Westmeath, Ireland,

REASON Dissolution failure (at stability testing).

VOLUME OF PRODUCT IN COMMERCE 8,646 bottles.

DISTRIBUTION Nationwide.

PRODUCT Risperdal (Risperidone) Tablets, 0.25mg, bottles of 60 and 500 tablets. Rx only Risperdal tablets, 0.25mg, are a prescription benzisoxazole antipsychotic agent in a solid dosage form intended for the management of the manifestations of psychotic disorders.

CODE Lot Number -- Expiration Date

500'S

90P0550 -- 3/31/02

90P0739 -- 3/31/02

90P0775 -- 9/30/02

91P0112E -- 9/30/02

91P0003 -- 10/31/02

91P0161 -- 12/31/02

91P0223 -- 1/31/03

91P0372 -- 1/31/03

91P0471 -- 3/31/03

91P0415 -- 3/31/03

91P0582 -- 3/31/02

91P0640E -- 3/31/03

91P1011 -- 5/31/03

91P1053E -- 5/31/03

91P0883 -- 5/31/03

60'S

90P0746E -- 9/30/02

90P0795E -- 9/30/02

91P0113 -- 10/31/02

91P0002 -- 10/31/02

91P0206E -- 12/31/02

91P0369 -- 1/31/03

91P0468E -- 1/31/03

91P0414 -- 3/31/03

91P0575E -- 3/31/03

91P0614E -- 3/31/03

91P0661E -- 3/31/03

91P0898 -- 5/31/03

91P0840 -- 5/31/03

91P1009 -- 5/31/03

91P1067E -- 6/30/03.

RECALLING FIRM/MANUFACTURER Recalling Firm: Pharmaceutical Sourcing Group Americas (Janssen ) Titusville, NJ

Manufacturer: Janssen-Cilag S.P.A Latina, Italy.

REASON Dissolution failure.

VOLUME OF PRODUCT IN COMMERCE 496370 bottles of 60's; 40925 bottles of 500.

DISTRIBUTION Nationwide

PRODUCT a) Derma-Smoothe/FS (Scalp Oil) Fluocinolone Acetonide 0.01% Topical Oil, Rx only, 4 fl. oz.;

b) Derma-Smoothe/FS, Atopic Pak, Fluocinolone Acetonide 0.01%, For Topical Use Only, 4 fl. ounce bottles, Rx only.

CODE a) Lots L000099, M000110, B010020, B010026, C010038 and D010045; b) Lots A010004 and C010030.

RECALLING FIRM/MANUFACTURER Hill Dermaceuticals, Inc. Sanford, FL

REASON Subpotency for Flucinolone Acetonide.

VOLUME OF PRODUCT IN COMMERCE 226,659 bottles.

DISTRIBUTION Nationwide and Canada.

WEEK ENDING JANUARY 26

PRODUCT Clonazepam Tablets, USP 1 mg, 500 tablet bottles, Rx only TEVA brand label

CODE Lot 356519 exp. 8/03

RECALLING FIRM/MANUFACTURER Recalling Firm: Teva Pharmaceuticals USA North Wales, PA

Manufacturer: Teva Pharmaceuticals Jerusalem, Israel.

REASON Misbranding - tablets debossed with incorrect code (93-832 for 0.5mg)

VOLUME OF PRODUCT IN COMMERCE 1904 bottles

DISTRIBUTION Nationwide