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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1701-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 6, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Generics Inc., USA
Original FDA data
Every field from FDA enforcement report D-1701-2012, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63264
- Address
- 750 Corporate Dr
- Code information
- Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.
- Postal code
- 07430-2009
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1701-2012
- Classification
- Class II
- Recalling firm
- Glenmark Generics Inc., USA
- Product quantity
- unknown
- Termination date
- Aug 13, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 6, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 27, 2012