Recalls / Class II

Class IID-1249-2015

Product

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.

Affected lot / code info

Lot #: LM11172, Expiry: 6/30/2015; Lot #: LN10487, Expiry: 1/31/2016; Lot #: LN10488, Expiry: 1/31/2016; Lot #: LN10489, Expiry: 2/29/2016; Lot #: LN10578, Expiry: 2/29/2016; Lot #: LN10581, Expiry: 2/29/2016; Lot #: LN10582, Expiry: 2/29/2016; Lot #: LN11068, Expiry: 4/30/2016; Lot #: LN11073, Expiry: 4/30/2016; Lot #: LN11125, Expiry: 5/31/2016; Lot #: LN11362, Expiry: 8/31/2016; Lot #: LN11379, Expiry: 8/31/2016; Lot #: LN11380, Expiry: 8/31/2016.

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

Recalling firm

Firm

Wockhardt Usa Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

20 Waterview Blvd Ste 3, N/A, Parsippany, New Jersey 07054-1271

Distribution

Quantity

59,729 Bottles

Distribution pattern

U.S. Nationwide including Puerto Rico.

Timeline

Recall initiated

2015-04-22

FDA classified

2015-07-17

Posted by FDA

2015-07-29

Terminated

2018-05-09

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1249-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.