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;
Reported: November 1, 2017 Initiated: August 22, 2017 #D-0051-2018
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;
Reason for Recall
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Details
- Recalling Firm
- Wockhardt Usa Inc.
- Units Affected
- 5050 bottles
- Distribution
- Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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;. Recalled by Wockhardt Usa Inc.. Units affected: 5050 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 1, 2017. Severity: Low. Recall number: D-0051-2018.
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