Reported Jul 29, 2015 · Terminated
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count…
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?
- Amlodipine Besylate Tablets, 5 mg Tablets
- Packaged as A) 90 Count Bottles (NDC64679-422-01)
- and B) 1000 Count Bottles (NDC64679-422-02), Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
53 of 53 products
Products covered by this recall # Product as published 1 DM11421, Expiry: 5/31/2015 2 Lot #: DM12956, Expiry: 10/31/2015 3 Lot #: DM12957, Expiry: 10/31/2015 4 Lot #: DM12963, Expiry: 10/31/2015 5 Lot #: DM13242, Expiry: 11/30/2015 6 Lot #: DM13243, Expiry: 11/30/2015 7 Lot #: DM13251, Expiry: 11/30/2015 8 Lot #: DM13260, Expiry: 11/30/2015 9 Lot #: DN10138, Expiry: 12/31/2015. B) Lot #: DM11035, Expiry: 4/30/2015 10 Lot #: DM11088, Expiry: 4/30/2015 11 Lot #: DM11389, Expiry: 5/31/2015 12 Lot #: DM11393, Expiry: 5/31/2015 13 Lot #: DM11394, Expiry: 5/31/2015 14 Lot #: DM12632, Expiry: 9/30/2015 15 Lot #: DM12633, Expiry: 9/30/2015 16 Lot #: DM12650, Expiry: 9/30/2015 17 Lot #: DM12651, Expiry: 9/30/2015 18 Lot #: DM12667, Expiry: 5/31/2015 19 Lot #: DM12964, Expiry: 10/31/2015 20 Lot #: DM13086, Expiry: 10/31/2015 - Amount recalled
- A) 146,959 Bottles, B) 73,445 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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