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 Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
Lot numbers, UPCs & expiration codes
Lot #160133, 160549 Exp. 08/17 Lot #162006; Exp. 09/17 Lot #163348A, 163348B; Exp. 10/17
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-0520-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 3, 2017
- FDA report date
- Mar 22, 2017
- Quantity
- 19,393 cartons (581,790 extended release tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services
Original FDA data
Every field from FDA enforcement report D-0520-2017, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 76636
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #160133, 160549 Exp. 08/17 Lot #162006; Exp. 09/17 Lot #163348A, 163348B; Exp. 10/17
- Postal code
- 43217-1188
- Report date
- Mar 22, 2017
- Product type
- Drugs
- Recall number
- D-0520-2017
- Classification
- Class II
- Recalling firm
- Amerisource Health Services
- Product quantity
- 19,393 cartons (581,790 extended release tablets)
- Termination date
- Mar 1, 2018
- 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 Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 3, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2017