FDAFDA · Food and drugs·Recall number D-0915-2018
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
Published July 18, 2018 · Recall initiated: June 25, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Recall details
- Manufacturer
- AMERICAN HEALTH PACKAGING
- Distributor
- Lot#166023 products distributed from 12/29/16 to 1/19/17 and Lot#168467 distributed from 4/6/17 to 9/11/17. Distributors are the wholesalers who received the product; others are the Corporate Offices for those wholesalers.
- Lot
- Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units).
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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