Home / Recalls / AMERICAN HEALTH PACKAGING / D-0915-2018

D-0915-2018 Class III Terminated

Recalled by AMERICAN HEALTH PACKAGING — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
July 18, 2018
Initiation Date
June 25, 2018
Termination Date
April 29, 2020
Voluntary/Mandated
Product Quantity
1285 cartons (cartons of 100 individual unit doses)

Product Description

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]

Reason for Recall

Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant

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.

Code Information

Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units).

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  • D-1372-2020 Class III — Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister (June 10, 2020)
  • D-1293-2020 Class II — Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx onl (May 19, 2020)