Corona, CA, United States
Aidarex Pharmaceuticals LLC recalls
2 recalls recorded since 2018, most recently on 27 June 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 27 June 2018
- Terminated
- 4 December 2019
- Reason
- Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0992-2018, D-0990-2018, D-0991-2018
- Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30
- Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
- Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
Terminated Class III Drugs
- Recall started
- 10 April 2018
- Terminated
- 4 December 2019
- Reason
- Presence of Foreign Tablets/Capsules
- Distribution
- Product was distributed to Florida
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0810-2018
- Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.