Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Tablet/Capsule Specifications: out of specification for thickness.
Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
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