Drug product
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]
D-0915-2018
Product summary
- Event
- Event 80389
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1285 cartons (cartons of 100 individual unit doses)
- Official record key
drug-enforcement:D-0915-2018
Official wording
Reason: Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Code information: Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units).
Distribution pattern: 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.
Derived failure modes
-
Potency or specification failure
out-of-specification