Reported Jul 29, 2015 · Terminated
Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC:…
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, 5 mg Tablets
- Packaged in A) 100 Count Bottles (NDC64679-928-01)
- B) 500 Count Bottles (NDC64679-928-05)
- and C) 1000 Count Bottles (NDC64679-928-06), Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
30 of 30 products
Products covered by this recall # Product as published 1 DM10991, Expiry: 4/30/2015 2 Lot #: DM11226, Expiry: 4/30/2015 3 Lot #: DM11665, Expiry: 6/30/2015 4 Lot #: DM11810, Expiry: 6/30/2015 5 Lot #: DM12702, Expiry: 9/30/2015 6 Lot #: DN10719, Expiry: 1/31/2016. B) Lot #: DM11651, Expiry: 6/30/2015 7 Lot #: DM11652, Expiry: 6/30/2015 8 Lot #: DM11664, Expiry: 6/30/2015 9 Lot #: DM12701, Expiry: 9/30/2015 10 Lot #: DN10139, Expiry: 12/31/2015. C) Lot #: DM11041, Expiry: 4/30/2015 11 Lot #: DM11267, Expiry: 4/30/2015 12 Lot #: DM11268, Expiry: 4/30/2015 13 Lot #: DM11279, Expiry: 5/31/2015 14 Lot #: DM11286, Expiry: 5/31/2015 15 Lot #: DM11292, Expiry: 5/31/2015 16 Lot #: DM11625, Expiry: 6/30/2015 17 Lot #: DM11626, Expiry: 6/30/2015 18 Lot #: DM11670, Expiry: 6/30/2015 19 Lot #: DM11772, Expiry: 6/30/2015 20 Lot #: DM11773, Expiry: 6/30/2015 - Amount recalled
- A) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Wockhardt USA Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.