Recalls / Class III
Class IIID-0991-2018
Product
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
- Affected 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.
Why it was recalled
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Recalling firm
- Firm
- Aidarex Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 595 N Smith Ave, N/A, Corona, California 92880-6920
Distribution
- Quantity
- 61, 90-count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2018-06-27
- FDA classified
- 2018-07-25
- Posted by FDA
- 2018-08-01
- Terminated
- 2019-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0991-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.