Why it was recalled
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Product description
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
Lot numbers, UPCs & expiration codes
Lot #: 3134201, 3134202, Exp. 06/30/17; 3134319, Exp. 05/31/17; 3135246, Exp. 07/31/17; 3135247, 3136781, Exp. 08/31/17; 3136782, Exp. 09/30/17; 3136903, 3136904, Exp.10/31/17; 3138250, Exp. 07/31/17; 3138968, Exp. 08/31/17; 3140000, Exp. 09/30/17
Where it was sold
Nationwide in US
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-0476-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 30, 2017
- FDA report date
- Feb 22, 2017
- Quantity
- 499320 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Inc
Original FDA data
Every field from FDA enforcement report D-0476-2017, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76406
- Address
- 400 Interpace Pkwy
- Code information
- Lot #: 3134201, 3134202, Exp. 06/30/17; 3134319, Exp. 05/31/17; 3135246, Exp. 07/31/17; 3135247, 3136781, Exp. 08/31/17; 3136782, Exp. 09/30/17; 3136903, 3136904, Exp.10/31/17; 3138250, Exp. 07/31/17; 3138968, Exp. 08/31/17; 3140000, Exp. 09/30/17
- Postal code
- 07054-1120
- Report date
- Feb 22, 2017
- Product type
- Drugs
- Recall number
- D-0476-2017
- Classification
- Class II
- Recalling firm
- Actavis Inc
- Product quantity
- 499320 units
- Termination date
- Mar 13, 2018
- Reason for recall
- Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
- Distribution pattern
- Nationwide in US
- Recall initiation date
- Jan 30, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2017