FDAFDA · Food and drugs·Recall number D-1701-2012
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.
Published October 3, 2012 · Recall initiated: July 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NAPROXEN SODIUM
- Manufacturer
- Glenmark Generics Inc., USA
- Distributor
- Nationwide
- UPC
- 0368462189016
- Lot
- Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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