Why it was recalled
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 3138405A, Exp 8/2017
Where it was sold
Product distributed to OH, IL, PA, MI, VA and CT
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-1058-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 2, 2017
- FDA report date
- Aug 16, 2017
- Quantity
- 2,880 cartons (30 unit dose blister pack per carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1058-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 77881
- Address
- 1090 Horsham Rd
- Code information
- Lot # 3138405A, Exp 8/2017
- Postal code
- 19454-1505
- Report date
- Aug 16, 2017
- Product type
- Drugs
- Recall number
- D-1058-2017
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 2,880 cartons (30 unit dose blister pack per carton)
- Termination date
- Feb 28, 2018
- Reason for recall
- Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product distributed to OH, IL, PA, MI, VA and CT
- Recall initiation date
- Aug 2, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2017