Reported Jul 29, 2015 · Terminated
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B)…
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?
- Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules
- Packaged as A) 100 Count Bottles (NDC64679-720-01)
- and B) 1000 Count Bottles (NDC64679-720-02), Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
12 of 12 products
Products covered by this recall # Product as published 1 DM11488, Expiry: 4/30/2015 2 Lot #: DM12093, Expiry: 6/30/2015 3 Lot #: DM12540, Expiry: 7/31/2015. B) Lot #: DM11412, Expiry: 4/30/2015 4 Lot #: DM11642, Expiry: 5/31/2015 5 Lot #: DM11682, Expiry: 5/31/2015 6 Lot #: DM12094, Expiry: 6/30/2015 7 Lot #: DM12533, Expiry: 7/31/2015 8 Lot #: DM12609, Expiry: 7/31/2015 9 Lot #: DM12898, Expiry: 9/30/2015, Lot #: DM12899, Expiry: 9/30/2015 10 Lot #: DN10163, Expiry: 11/30/2015 11 Lot #: DN10273, Expiry: 11/30/2015 12 Lot #: DN10487, Expiry: 12/31/2015. - Amount recalled
- 53,894 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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