D-0520-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 22, 2017
- Initiation Date
- February 3, 2017
- Termination Date
- March 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,393 cartons (581,790 extended release tablets)
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
Reason for Recall
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Distribution Pattern
Nationwide
Code Information
Lot #160133, 160549 Exp. 08/17 Lot #162006; Exp. 09/17 Lot #163348A, 163348B; Exp. 10/17