Drug recall D-1701-2012
Product
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.
Lots and codes
Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.
Recall details
- Recalling firm
- Glenmark Generics Inc., USA, Mahwah, NJ
- Quantity
- unknown
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 6, 2012
- Terminated
- August 13, 2015
Related products
- Naproxen Sodium – drug information
- NDC 68462-179 Naproxen Sodium · Naproxen Sodium 550 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-178 Naproxen Sodium · Naproxen Sodium 275 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-189 Naproxen · Naproxen 375 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-188 Naproxen · Naproxen 250 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-190 Naproxen · Naproxen 500 mg/1 · Glenmark Pharmaceuticals Inc., USA