Enalapril Maleate tablets recall: Impurity Out of Spec
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;
Why was Enalapril Maleate tablets recalled?
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019.
- Product
- 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;
- Recalling firm
- Wockhardt Usa Inc.
- Quantity
- 5050 bottles
- Distribution
- Nationwide in the USA
- Recall date
- November 1, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)