Reported Jul 29, 2015 · Terminated
Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches…
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
Is this the product you have?
- Azithromycin Tablets, USP, 250 mg Tablets
- Packaged in A) 30 Count Bottles (NDC
64679-0961-01)B) 3500
- Count Pouches (NDC64679-961-08)
- and C) 3 x 6 Tablet Card Cartons (NDC64679-961-05), Rx only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
51 of 51 products
Products covered by this recall # Product as published 1 LM10712, Expiry: 4/30/2015 2 Lot #: LM10874, Expiry: 4/30/2015 3 Lot #: LM11040, Expiry: 5/31/2015 4 Lot #: LM11169, Expiry: 6/30/2015 5 Lot #: LM11401, Expiry: 6/30/2015 6 Lot #: LM12132, Expiry: 11/30/2015 7 Lot #: LN10039, Expiry: 12/31/2015 8 Lot #: LN10263, Expiry: 12/31/2015 9 Lot #: LN10276, Expiry: 12/31/2015 10 Lot #: LN10417, Expiry: 1/31/2016, Lot #: LN11365, Expiry: 8/31/2016. B) Lot #: LN11264, Expiry: 7/31/2015 11 Lot #: LN11373, Expiry: 8/31/2015 12 Lot #: LN11375, Expiry: 8/31/2015. C) Lot #: LM10686, Expiry: 4/30/2015 13 Lot #: LM10757, Expiry: 4/30/2015 14 Lot #: LM10855, Expiry: 4/30/2015 15 Lot #: LM10893, Expiry: 5/31/2015 16 Lot #: LM10945, Expiry: 5/31/2015 17 Lot #: LM10989, Expiry: 4/30/2015 18 Lot #: LM11117, Expiry: 6/30/2015 19 Lot #: LM11168, Expiry: 6/30/2015 20 Lot #: LM11214, Expiry: 6/30/2015 - Amount recalled
- A) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 Cartons.
This recall covers 35 products
The agency filed one notice per product. You are reading one of them; the other 34 are below.
22 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
This product could cause temporary or reversible health problems — stop using it.
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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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