Teva Recalls Glipizide Extended-Release Tablets Due to Moisture Limit Failures
Teva Pharmaceuticals USA is recalling 2,880 cartons of Glipizide Extended-Release Tablets, 5 mg, because stability testing revealed out-of-specification water content.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA is recalling 2,880 cartons of Glipizide Extended-Release Tablets, 5 mg, packaged in 30-unit dose blister packs. The product is manufactured for Watson Laboratories, Inc., and manufactured by Patheon Pharmaceuticals, Inc. The specific lot number is 3138405A, with an expiration date of 8/2017.
The recall was initiated due to failed moisture limits, specifically out-of-specification test results for water content obtained during stability testing. This is an FDA Class III recall, which indicates that the violation is not likely to cause adverse health consequences.
The affected product was distributed to Ohio, Illinois, Pennsylvania, Michigan, Virginia, and Connecticut. Consumers and healthcare providers should check their inventory for this specific NDC (0591-0844-15) and lot number. If found, the product should be returned to the pharmacy or distributor for credit.
The recalled product
- Product
- Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Anti-diabetic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 3138405A
- Exp 8/2017
Distribution
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