FDA Drug Class II — Moderate

Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.

Hazard

CGMP Deviations: Firm did not adequately investigate customer complaints.

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Products

Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ
Brand
Wockhardt Usa Inc.
UPC
Lot #: LN10991, Expiry: 4/30/2015; Lot #: LN11381, Expiry: 7/31/2015.

Units Affected

7,584 Bottles

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