RecallRadar

FDA Drug recall D-1249-2015

Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only

On 2015-07-29 the FDA classified a Class II recall of Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only by Wockhardt Usa, citing CGMP Deviations: Firm did not adequately investigate customer complaints.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1249-2015
ClassificationClass II
Statusterminated
Initiated2015-04-22
Published2015-07-29
Last updated2026-09-13 11:51 UTC
CompanyWockhardt Usa
DistributionUS

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.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_info
Lot #: LM11172, Expiry: 6/30/2015; Lot #: LN10487, Expiry: 1/31/2016; Lot #: LN10488, Expiry: 1/31/2016; Lot #: LN10489…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1249-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.