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9/24/2001

Glyburide Tablets Recalled Because of Fungal Contamination

Cheryl A. Thompson

Pharmacia Corp. and its subsidiary Greenstone Ltd. announced Friday that they are recalling several lots of glyburide tablets because of contamination with fungi, including Aspergillus, Paecilomyces, and Penicillium species. Health care providers have been advised to urge patients to continue to use their current supply of glyburide until they obtain or receive a replacement.

Pharmacia is recalling the following lots of the Micronase brand of glyburide, sold in bottles of 100 tablets:

84DWB (1.25 mg),

91DYR (2.5 mg), and

67FPP (5 mg).

Greenstone is recalling the following lots of glyburide, sold in bottles of 100, 500, or 1,000 tablets:

37DYR, 84DTF (1.25 mg),

40FCW, 42FCW, 44FCW, 46FCW, 76DWD, 88DTF (2.5 mg), and

02FJX, 07FMF, 10FMF, 11FMF, 12FTH, 14FJX, 15FJX, 15FKS, 16FKS, 17FKS, 17FTH, 18FKS, 18FTD, 18FTH, 19FKS, 19FTH, 22FKS, 28FMK, 39FTD, 43FKW, 44FMD, 57FJD, 58FJD, 59FMD, 60FJD, 61FJD, 74FKR, 75FKR, 85FMU, 86FMH, 93FRY, 95FRY, 96FRY (5 mg).

The companies identified the source of the contamination as a raw material used in the formulation of the tablets.

According to the companies' review of the literature, no one has become infected after eating or swallowing material containing Aspergillus, Paecilomyces, or Penicillium species. However, infections with these fungi have occurred, on rare occasion, after inhalation or entry through damaged skin.

The companies said they will provide shipping labels for use in returning tablets in the recalled lots. Credit for the returned tablets will be issued through the purchaser's wholesaler. The companies are directing questions about the recall to 800-323-4204 (8 a.m. to 5 p.m. EST).