Reported Jul 29, 2015 · Terminated
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited,…
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, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- NDC64679-421-01
- Lot codes and dates
13 of 13 products
Products covered by this recall # Product as published 1 DM11774, Expiry: 6/30/2015 2 Lot #: DM13056, Expiry: 10/31/2015 3 Lot #: DM13117, Expiry: 10/31/2015 4 Lot #: DM13159, Expiry: 10/31/2015 5 Lot #: DM13186, Expiry: 10/31/2015 6 Lot #: DM13187, Expiry: 10/31/2015 7 Lot #: DM13188, Expiry: 10/31/2015 8 Lot #: DN10003, Expiry: 11/30/2015 9 Lot #: DN10045, Expiry: 11/30/2015 10 Lot #: DN10046, Expiry: 11/30/2015 11 Lot #: DN10389, Expiry: 1/31/2016 12 Lot #: DN10412, Expiry: 1/31/2016 13 Lot #: DN10604, Expiry: 1/31/2016. - Amount recalled
- 124,034 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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