Why it was recalled
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Product description
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
Lot numbers, UPCs & expiration codes
Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
Where it was sold
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-0051-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Nov 1, 2017
- Quantity
- 5050 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wockhardt Usa Inc.
Original FDA data
Every field from FDA enforcement report D-0051-2018, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77951
- Address
- 20 Waterview Blvd Ste 3
- Code information
- Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
- Postal code
- 07054-1271
- Report date
- Nov 1, 2017
- Product type
- Drugs
- Recall number
- D-0051-2018
- Classification
- Class III
- Recalling firm
- Wockhardt Usa Inc.
- Product quantity
- 5050 bottles
- Termination date
- Feb 27, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 26, 2017