Why it was recalled
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Product description
GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
Lot numbers, UPCs & expiration codes
Lot # 181288, EXP 5/31/2020
Where it was sold
Nationwide in the USA
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-1276-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 8, 2019
- FDA report date
- May 8, 2019
- Quantity
- 2,203 cartons (cartons of 30 individual unit doses)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1276-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 82593
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot # 181288, EXP 5/31/2020
- Postal code
- 43217-1188
- Report date
- May 8, 2019
- Product type
- Drugs
- Recall number
- D-1276-2019
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 2,203 cartons (cartons of 30 individual unit doses)
- Termination date
- Nov 6, 2020
- Reason for recall
- Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 8, 2019
- Initial firm notification
- Letter
- Center classification date
- May 10, 2019