Recalls / Class II
Class IID-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.
- Brand name
- Naproxen Sodium
- Generic name
- Naproxen Sodium
- Active ingredient
- Naproxen Sodium
- Route
- Oral
- NDCs
- 68462-178, 68462-188, 68462-189, 68462-190, 68462-179
- FDA application
- ANDA078314
- Affected lot / code info
- Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.
Why it was recalled
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Recalling firm
- Firm
- Glenmark Generics Inc., USA
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-07-06
- FDA classified
- 2012-09-27
- Posted by FDA
- 2012-10-03
- Terminated
- 2015-08-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1701-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.