Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #:18020994, Expiry: October 2015; Lot #: 18021311, Expiry: November 2015.
Where it was sold
U.S. Nationwide including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0436-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 25, 2015
- FDA report date
- Apr 15, 2015
- Quantity
- 6,816 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Heritage Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0436-2015, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 70845
- Address
- 12 Christopher Way Ste 300
- Code information
- Lot #:18020994, Expiry: October 2015; Lot #: 18021311, Expiry: November 2015.
- Postal code
- 07724-3331
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D-0436-2015
- Classification
- Class II
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Product quantity
- 6,816 Bottles
- Termination date
- May 15, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
- Recall initiation date
- Mar 25, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 7, 2015