Reported Jul 29, 2015 · Terminated

Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet…

Wockhardt USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd Ste 3 · Parsippany, NJ · 07054-1271

Lot codes and dates: 16 of 16 products
Products covered by this recall
# Product as published
1 LM10739, Expiry: 4/30/2015
2 Lot #: LM10991, Expiry: 5/31/2015
3 Lot #: LM11264, Expiry: 6/30/2015
4 Lot #: LM12019, Expiry: 11/30/2015
5 Lot #: LN10100, Expiry: 12/31/2015
6 Lot #: LN10220, Expiry: 12/31/2015
7 Lot #: LN10227, Expiry: 12/31/2015
8 Lot #: LN10228, Expiry: 12/31/2015
9 Lot #: LN11405, Expiry: 9/30/2016. B) Lot #: LM11015, Expiry: 5/31/2015
10 Lot #: LM11609, Expiry: 9/30/2015
11 Lot #: LM11883, Expiry: 10/31/2015
12 Lot #: LM11918, Expiry: 10/31/2015
13 Lot #: LN10274, Expiry: 12/31/2015
14 Lot #: LN11045, Expiry: 4/30/2016
15 Lot #: LN11327, Expiry: 12/31/2015
16 Lot #: LN11332, Expiry: 7/31/2016.
Amount recalled: A) 112,120 Bottles and B) 178,580 Cartons.

The agency filed one notice per product. You are reading one of them; the other 34 are below.

22 more are in the archive.

CGMP Deviations: Firm did not adequately investigate customer complaints.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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9 in total.