Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30

FDA recall notice · announced August 1, 2018 · Aidarex Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lots: 51904-2, EXP: 01/31/2018; 51904-3, EXP: 02/28/2018; 51904-5, EXP: 03/31/2018; 52885-2, EXP: 03/31/2018, 53840-1, EXP: 5/28/2018.
Quantity: 25, 30-count bottles
Status: Terminated
Products in this recall event:
- Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90 (D-0990-2018)
- Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90 (D-0991-2018)
- Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30 (D-0992-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.