Reported Jul 29, 2015 · Terminated
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles…
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?
- Captopril Tablets, USP, 25 mg Tablets
- Packaged in A) 100 Count Bottles (NDC64679-0903-01)
- and B) 1000 Count Bottles (NDC64679-0903-02), Rx only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
29 of 29 products
Products covered by this recall # Product as published 1 LM10843, Expiry: 5/31/2015 2 Lot #: LM11331, Expiry: 7/31/2015 3 Lot #: LM11332, Expiry: 7/31/2015 4 Lot #: LM11376, Expiry: 7/31/2015 5 Lot #: LM11583, Expiry: 8/31/2015 6 Lot #: LM11987, Expiry: 11/30/2015 7 Lot #: LN10065, Expiry: 12/31/2015 8 Lot #: LN10066, Expiry: 12/31/2015 9 Lot #: LN10334, Expiry: 1/31/2016 10 Lot #: LN10335, Expiry: 1/31/2016 11 Lot #: LN10443, Expiry: 1/31/2016 12 Lot #: LN10879, Expiry: 4/30/2016 13 Lot #: LN10971, Expiry: 4/30/2016 14 Lot #: LN11178, Expiry: 6/30/2016 15 Lot #: LN11184, Expiry: 6/30/2016 16 Lot #: LN11348, Expiry: 7/31/2016. B) Lot #: LM10683, Expiry: 4/30/2015 17 Lot #: LM10842, Expiry: 5/31/2015 18 Lot #: LM11377, Expiry: 7/31/2015 19 Lot #: LM11584, Expiry: 8/31/2015 20 Lot #: LM11985, Expiry: 11/30/2015 - Amount recalled
- A) 162,743 Bottles and B) 14,205 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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