JULY 2001

WEEK ENDING JULY 7

PRODUCT AND CODE: ADAGEN (pegademase bovine injection) 250 units per mL. Intramuscular use only 1.5 mL single-dose vials (units of 4) Rx only. NDA 19-818

REASON: Cross contamination with FOMEPIZOLE (4-METHYL-PYRAZOLE)

MANUFACTURER/RECALLING FIRM: Enzon, Inc, Piscataway, NJ

DISTRIBUTION: CA, FL, IL, LA, MD, MA, NY, NC, OH, OK, TN, TX, UT and including Japan, Australia, Canada, Denmark, Croatia, France, Germany, Italy, Switzerland, and Spain

QUANTITY: 792 vials

PRODUCT AND CODE: Serostim, 6 mg. vials (somatropin rDNA origin for injection), 7 vials per carton with 7 vials of sterile diluent. Lot Number MNH605A, Exp. 4/02

REASON: COUNTERFEIT

MANUFACTURER: Unknown

DISTRIBUTION: GA, SC and SC

QUANTITY: 4 cartons, 7 x 6 mg. vials per carton

WEEK ENDING JULY 14

PRODUCT AND CODE: Phenytoin Sodium 100mg, Prompt Release Capsules, Zenith Goldline, Label, 100 count bottles, NDC#0172-2057-60, ANDA# -- 80-259, Product code is #2057, Lot Number is 268 Exp. 2/01

REASON: DISSOLUTION FAILURE (18 MONTH STABILITY)

MANUFACTURER/RECALLING FIRM: Zenith Goldline Pharmaceuticals Northvale, NJ

DISTRIBUTION: Nationwide

QUANTITY: 18,963 bottles

PRODUCT AND CODE: Methocarbamol and Aspirin Tablets 400mg/325mg; Rx Zenith Goldline, NDC#0172-2813-60

Lot Numbers: 2813-098-- 6/2001

2813--99V--5/2002

2813-100V--6/2002

REASON: SUPER-POTENCY-(ASPIRIN COMPONE NT)

MANUFACTURER/RECALLING FIRM: Zenith Goldline Pharmaceuticals Northvale, NJ

DISTRIBUTION: Nationwide

QUANTITY: 9235 x 100 tablet bottles

PRODUCT AND CODE: Capzasin-HP Lotion, 2 fl oz (59.1 mL), containing the active ingredient-Capsaicin, 0.075%, NDC No. 41167-6505-6. The product is packaged with a touch free applicator and sold (OTC) boxed as individual units. Lot 00D403, EXP 04/02

REASON: SUB-POTENCY (STABILITY FAILURE AT 12 MONTHS)

MANUFACTURER/RECALLING FIRM: Chattem, Inc., Chattanooga, TN

DISTRIBUTION: Nationwide

QUANTITY: 11,064

PRODUCT AND CODE: Aspirin Tablets, Film Coated, 325 mg. (5 gr); an OTC analgesic; Packaged in Robot Ready blister packages of 25 and unit dose blister packages of 100, 200 and 500.

Lots 0H624, 0P219, 1C014, 0H616, 0K043, 0P237, 1C991, 1C044 lots 0F530, 0K971, 1C982, 0F524, 0K963, 1C974

REASON: FAILED DISSOLUTION SPECIFICATIONS (AT STABILITY TESTING

MANUFACTURER: LNK International, Inc., Hauppage, NY

RECALLED BY: UDL Laboratories, Inc., Rockford, IL

DISTRIBUTION: Nationwide

QUANTITY: 16,196,325 tablets

Ultra Botanicals, Inc. of Los Angeles, CA, is recalling all lots of its 1 ounce bottles of "MSM Eye Drops" and "MSM Eyes & Nasal Drops" due to potentially serious health risks associated with bacterial contamination and the lack of evidence demonstrating the safety of MSM for use in the eyes or nose.

Samples analyzed by the Food and Drug Administration were found to contain Pseudomonas mendocina and Klebsiella pneumoniae, bacteria that in some cases can cause sight-threatening injury. The recalled "MSM Eye Drops" were distributed nationwide and sold in retail stores. The recalled "MSM Eyes & Nasal Drops" were sold directly to consumers. Both products are manufactured in 1 ounce dropper bottles. "MSM Eye Drops" are labeled and sold under the Ultra Botanicals brand, while "MSM Eyes & Nasal Drops" were distributed under the All That's Natural brand. To date, there have been no reports of injury in connection with these products. Individuals who have used these products and have experienced any adverse reactions are advised to contact their healthcare provider.

Consumers who have purchased 1-ounce bottles of "MSM Eye Drops" or "MSM Eyes & Nasal Drops" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-357-7655.

WEEK ENDING JULY 21

PRODUCT AND CODE: Deltasone 10 mg. tablets [prednisone tablets, USP] in 500 tablet bottles. Rx. CODE: Lot 29DRB. Exp. 9/2004.
REASON: Tablet mix-up, bottles labeled to contain 10 mg tablets may contain 5 mg tablets.
MANUFACTURER/RECALLING FIRM: Pharmacia Corporation, Kalamazoo, MI 49001
DISTRIBUTION: Nationwide
QUANTITY: 6,792 bottles

PRODUCT AND CODE: AndroGel Testosterone Gel 1%, 5 gram unit does aluminum foil packets, 30 packets per carton; NDC #0051-8450-30
CODE: Lot 00207, exp.05/02
REASON: SUBPOTENCY (AT RELEASE)
MANUFACTURER: Laboratories Besins Iscovesco, Montrouge, France
RECALL BY: Unimed Pharmaceuticals, Inc., Deerfield,
DISTRIBUTION: IL, ND, FL, PA, IN, TN AZ, NY MA, NJ, KY
QUANTITY: 1,512 cartons

PRODUCT AND CODE: Vira-A [Vidarabine Ophthalmic Ointment, USP] 3% sterile ophthalmic ointment; 3.5 gm tubes. Rx. 1 tube cartons and 12 tube cartons.
REASON: Stability Failure (9 month assay)
MANUFACTURER Warner Lambert Co., Rochester, MI
RECALL BY: King Pharmaceuticals, Inc., Bristol TN
DISTRIBUTION: Nationwide
QUANTITY: Lot.No.5550-1, 39,326 units and Lot No. 53D0-1, 12 units

PRODUCT AND CODE: Cortisporin TC, a topical antibiotic/steroid, 10mL.
REASON: SUBPOTENCY (Colistin Sulfate Ingredient at 9 month stability)
MANUFACTURER Warner-Lambert Co, Rochester, MI 48407
RECALL BY: King Pharmaceuticals, Bristol, TN
DISTRIBUTION:Nationwide
QUANTITY: 23,316 units

PRODUCT AND CODE: Extra strength enteric-coated aspirin tablets, 500 mg in 60 tablet bottles, packaged under three labels as follows:
Equate (Walmart) Lot number: 0044685 Expiration: 3/01
Bi-Mart (Eugene, OR) Lot number: 8E01222 Expiration: 3/01
Western Family (Portland, OR) Lot number: 8E01222 Expiration: 3/01
REASON: DISSOLUTION TEST FAILED
MANUFACTURER INK International, Hauppauge, NY 11788
RECALL BY: Leiner Health Products, Carson, CA (Lot 8E01222) and Leiner health products, Largo, Fl. (Lot 0044685)
DISTRIBUTION: AR and OR
QUANTITY: Equate Label (lot 0044685) = 5,328 bottles; Bi-Mart Label (lot 8E01222) = 1,728 bottles; Western Family Label (lot 8E01222) = 8,136 bottles

WEEK ENDING JULY 28

PRODUCT AND CODE: A)Children’s Benadryl Allergy & cold FASTMELT Tablets, Cherry flavored B)Benadryl Allergy Kapseals or Ultratab tablets packaged in a 48 count box and including a free, 10-count tablet sample of Benadryl Allergy & Sinus FASTMELT.

C)Benadryl Allergy & Sinus FASTMELT, box of 20 tablets Note: It is the FASTMELT product only that is the focus of this recall action.

Allergy & Sinus Fastmelt 10 Tablet Free Sample Inside All lots; all configurations and all lots of Benadryl Allergy 48 count Ultratabs/Kapseals containing 10-count FASTMELT product

REASON: Mislabeled; Phenylalanine amount is 4.6 mg per tablet/capsule but labeled to contain 1.2 mg

MANUFACTURER: Shaklee Technica, Norman, OK

RECALLED BY: Warner Lambert Consumer Group, Pfizer Inc

DISTRIBUTION: Nationwide

QUANTITY: 88403 cases (24 units/case); 2, 382,429 prof. Samples; 36,780 displays

PRODUCT AND CODE: Levothyroxine Sodium Tablet 25 mcg. in bottles of 100's and 1000's. Lots - 029011A, 029011B, 029011D, 030011A, 031011A, 031011B Levothyroxine Sodium Tablets 50 mcg. in bottles of 100's and 1000's.

CODES: Lots - 009040A, 009040B, 009040C, 025070A, 025070B, 025070C, 025070D, 026070A, 073090A, 073090B, 073090C, 073090D, 014100A, 001110A, 001110B, 002110A, 002110B, 002110C

REASON: Stability; May not maintain potency through the expiration date.

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

DISTRIBUTION: Nationwide

QUANTITY Levothyroxine Sodium 0.025 mg. - 21,861 bottles were manufactured and distributed; Levothyroxine Sodium 0.050 mg - 18,718 bottles were manufactured and distributed.

PRODUCT AND CODE: Rx) Levothyroxine Sodium, USP Tablets, 25 mcg (0.025mg), 100 and 1,000 tablets Lots 083100B, 083100C, 018060A, 018060B, 018060C, 018060D Rx) Levothyroxine Sodium, USP Tablets, 50 mcg (0.05mg), 100 and 1,000 tablets Lots 089089I, 089089J, 011030A, 012030A, 012030B, 012030C, 010040A, 119050A, 120050A, 120050B, 120050C, 120050D, 120050E, 014080A, 015080A, 015080B Rx) Levothyroxine Sodium, USP Tablets, 75 mcg (0.075mg), 100 and 1,000 tablets

- Lots 148080A, 104080A, 104080B, 104080C, 107070A, 019060A, 019060B, 019060C, 019060D, 019060E, 019060F, 121050A, 121050B, 121050C, 012040A, 012040B, 012040C, 011040A, 011040B, 051090A, 052090A, 052090B, 052090C, 093090A, 093090B, 093090C, 093090D, 094090A, 094090B, 094090C, 094090D, 085100A, 085100B, 085100C, 116059A, 116059B

REASON: Stability data does not support expiry date

MANUFACTURER/RECALLING FIRM: Vintage Pharmaceuticals, Charlotte, NC

DISTRIBUTION: Nationwide

QUANTITY: 16,996 bottles

PRODUCT AND CODE: Levothyroxine Sodium 0.075 mg. Rx Tablets, USP under the QT, VPI and URL labels. The product is packaged in 100 and 1000 tablet bottles. Code: Lots 021129A, 021129B, 022129A, 022129B, 022129C, 022129D, 010030A, 010030B, 010030C, 010030D

REASON: Stability data does not support expiry date

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

DISTRIBUTION: Nationwide

QUANTITY 36, 578 bottles

PRODUCT AND CODE: Levothyroxine Sodium 0.025 mg - Lots 013030A, 013030B, 013030C Levothyroxine Sodium 0.075 mg - Lots 116059A, 116059B

REASON: The product may not maintain potency through the expiry date

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

DISTRIBUTION: Nationwide

QUANTITY: Levothyroxine Sodium 0.025 mg. - 22,186 bottles were manufactured and distributed; Levothyroxine Sodium 0.075 mg. - 2,910 bottles were manufactured and distributed.

PRODUCT AND CODE: Q Tuss Tablets in bottles of 100's and 500's. The product is under the Zenith Goldline, URL, QT, VPI and URL label. Lots - 010079A, 010079B, 010079C, 097089A, 098089A, 098089B, 098089C, 098089D, 098089E, 098089F, 099089A, 099089B, 136039A, 136039B, 136039C, 136039D, 008119A, 010119A, 011119A, 011119B, 011119C, 011119D, 011119E, 011119F, 009119A, 009119B, 009119C, 009119D, 009119E, 009119F, 011079A, 011079B, 011079C, 011079D, 011079E, 013090A, 013090B, 013090C, 100020C, 100020D, 012090A, 012090B

REASON: Super-Potency (Scopolamine)

MANUFACTURER/RECALLING FIRM: Vintage Pharmaceuticals, Charlotte, NC

DISTRIBUTION: Nationwide

QUANTITY: Q-Tuss Tablets - 110,538 bottles

PRODUCT AND CODE: Oxycodone HCL/Acetaminophen 5/500 mg Rx Capsules under the Vintage and Qualitest labels.

The product is packaged in 100 capsule bottles. Code: Lot 126060A and 126060B

REASON: Dissolution failure (Acetaminophen)

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

FIRM INITIATED RECALL: Ongoing

DISTRIBUTION: Nationwide

QUANTITY: 9,425 bottles