D-1701-2012 Class II Terminated
FDA drug recall D-1701-2012 was initiated by Glenmark Generics Inc., USA on July 6, 2012 and is designated Class II. Reason for recall: Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg. The recall status is terminated (terminated August 13, 2015). Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2012
- Initiation Date
- July 6, 2012
- Termination Date
- August 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
Reason for Recall
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Distribution Pattern
Nationwide
Code Information
Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.