Reported Jul 29, 2015 · Terminated
Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai,…
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?
- Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- NDC64679-949-01
- Lot codes and dates
13 of 13 products
Products covered by this recall # Product as published 1 LM11172, Expiry: 6/30/2015 2 Lot #: LN10487, Expiry: 1/31/2016 3 Lot #: LN10488, Expiry: 1/31/2016 4 Lot #: LN10489, Expiry: 2/29/2016 5 Lot #: LN10578, Expiry: 2/29/2016 6 Lot #: LN10581, Expiry: 2/29/2016 7 Lot #: LN10582, Expiry: 2/29/2016 8 Lot #: LN11068, Expiry: 4/30/2016 9 Lot #: LN11073, Expiry: 4/30/2016 10 Lot #: LN11125, Expiry: 5/31/2016 11 Lot #: LN11362, Expiry: 8/31/2016 12 Lot #: LN11379, Expiry: 8/31/2016 13 Lot #: LN11380, Expiry: 8/31/2016. - Amount recalled
- 59,729 Bottles
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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