D-1276-2019 Class II Terminated
FDA drug recall D-1276-2019 was initiated by American Health Packaging on April 8, 2019 and is designated Class II. 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. The recall status is terminated (terminated November 6, 2020). Affected quantity: 2,203 cartons (cartons of 30 individual unit doses).
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2019
- Initiation Date
- April 8, 2019
- Termination Date
- November 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,203 cartons (cartons of 30 individual unit doses)
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
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 181288, EXP 5/31/2020