Class III
Terminated
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
- Company
- Aidarex Pharmaceuticals Llc
- Recall Initiated
- June 27, 2018
- Posted
- August 1, 2018
- Recall Number
- D-0991-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 61, 90-count bottles
- Firm Location
- Corona, CA, United States
Reason for Recall
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lots: 51904-1, EXP: 01/31/2018; 51904-4, 52885-1, EXP: 03/31/2018; 52885-3, EXP: 04/30/2018; 52885-4,EXP: 05/28/2018; 53840-2,EXP: 5/28/2018; 53840-3, EXP:6/30/2018; 53840-4, EXP:8/31/2018; 56665-1, EXP: 01/31/2019; 58596-1, EXP: 05/28/2019.
More recalls by Aidarex Pharmaceuticals Llc
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
May 23, 2018 · Class III
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged...
Nov 1, 2017 · Class III
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, C...
Sep 20, 2017 · Class III
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