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
Reported: May 8, 2019 Initiated: April 8, 2019 #D-1276-2019
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.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 2,203 cartons (cartons of 30 individual unit doses)
- Distribution
- Nationwide in the USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by American Health Packaging. Units affected: 2,203 cartons (cartons of 30 individual unit doses).
Why was this product recalled? ▼
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 8, 2019. Severity: Moderate. Recall number: D-1276-2019.
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