Why it was recalled
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Product description
Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
Lot numbers, UPCs & expiration codes
Lots: 56698-1, EXP 1/31/2019; 56698-2, EXP 4/30/2019
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0990-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 27, 2018
- FDA report date
- Aug 1, 2018
- Quantity
- 11, 90-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidarex Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-0990-2018, exactly as published.
Show all FDA fields
- City
- Corona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 80397
- Address
- 595 N Smith Ave
- Code information
- Lots: 56698-1, EXP 1/31/2019; 56698-2, EXP 4/30/2019
- Postal code
- 92880-6920
- Report date
- Aug 1, 2018
- Product type
- Drugs
- Recall number
- D-0990-2018
- Classification
- Class III
- Recalling firm
- Aidarex Pharmaceuticals LLC
- Product quantity
- 11, 90-count bottles
- Termination date
- Dec 4, 2019
- Reason for recall
- Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jun 27, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 25, 2018