Reported Jul 29, 2015 · Terminated
Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 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?
- Lisinopril Tablets USP, 2.5 mg Tablets
- Packaged in A) 100 Count Bottles (NDC64679-927-01)
- and B) 500 Count Bottles (NDC64679-927-05), Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 1 DM10573, Expiry: 4/30/2015 2 Lot #: DM11531, Expiry: 5/31/2015 3 Lot #: DM11532, Expiry: 5/31/2015 4 Lot #: DM11676, Expiry: 6/30/2015 5 Lot #: DM11677, Expiry: 6/30/2015 6 Lot #: DM12543, Expiry: 8/31/2015 7 Lot #: DM13333, Expiry: 11/30/2015 8 Lot #: DN10272, Expiry: 12/31/2015 9 Lot #: DN10405, Expiry: 12/31/2015 10 Lot #: DN10446, Expiry: 1/1/2016. B) Lot #: DM11122, Expiry: 4/30/2015 11 Lot #: DM11130, Expiry: 4/30/2015 12 Lot #: DM11533, Expiry: 5/31/2015 13 Lot #: DM11674, Expiry: 6/30/2015 14 Lot #: DM11675, Expiry: 6/30/2015 15 Lot #: DM12497, Expiry: 8/31/2015 16 Lot #: DM13336, Expiry: 11/30/2015 17 Lot #: DN10289, Expiry: 12/31/2015 18 Lot #: DN10445, Expiry: 1/31/2016 19 Lot #: DN10816, Expiry: 1/31/2016 20 Lot #: DN10817, Expiry: 1/31/2016 - Amount recalled
- A) 149,924 Bottles and B) 35,012 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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