Recalls / Class II
Class IID-0436-2015
Product
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.
- Brand name
- Glipizide And Metformin Hcl
- Generic name
- Glipizide And Metformin Hcl
- Active ingredients
- Glipizide, Metformin Hydrochloride
- Route
- Oral
- NDCs
- 23155-115, 23155-116, 23155-117
- FDA application
- ANDA078728
- Affected lot / code info
- Lot #:18020994, Expiry: October 2015; Lot #: 18021311, Expiry: November 2015.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Recalling firm
- Firm
- Heritage Pharmaceuticals, Inc.
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 12 Christopher Way Ste 300, N/A, Eatontown, New Jersey 07724-3331
Distribution
- Quantity
- 6,816 Bottles
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2015-03-25
- FDA classified
- 2015-04-07
- Posted by FDA
- 2015-04-15
- Terminated
- 2017-05-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0436-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.