Why it was recalled
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Product description
Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
Lot numbers, UPCs & expiration codes
Lot # 3132593, 3132594, 3134420, 3134421,3134422, Exp. 02/17
Where it was sold
Nationwide
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-1457-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 30, 2016
- FDA report date
- Aug 24, 2016
- Quantity
- 167,152 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-1457-2016, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74702
- Address
- 400 Interpace Pkwy
- Code information
- Lot # 3132593, 3132594, 3134420, 3134421,3134422, Exp. 02/17
- Postal code
- 07054-1120
- Report date
- Aug 24, 2016
- Product type
- Drugs
- Recall number
- D-1457-2016
- Classification
- Class II
- Recalling firm
- Actavis Inc
- Product quantity
- 167,152 bottles
- Termination date
- Jul 3, 2017
- Reason for recall
- Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 30, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 15, 2016