Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.
Recall Number: D-1249-2015
Firm: Wockhardt Usa Inc.
Classification: Class II
Status: Terminated
Report Date: 20150729
Initiation Date: 20150422
Termination Date: 20180509
Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product Description
Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.