FDAFDA · Food and drugs·Recall number D-330-2013
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430
Published May 22, 2013 · Recall initiated: April 5, 2013
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
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Glenmark Generics Inc., USA
- Distributor
- Nationwide
- UPC
- 0368462195901
- Lot
- Lot # 02121059 Exp 03/15 Lot # 02121484 Exp 04/15 Lot # 02121530 Exp 04/15 Lot# 02121665 Exp 05/15 Lot# 02121669 Exp 05/15 Lot# 02121689 Exp 05/15 Lot# 02121705 Exp 05/15 Lot# 02123434 Exp 10/15 Lot# 02123446 Exp 10/15 Lot# 02123633 Exp 11/15 Lot# 02123677 Exp 11/15 Lot# 02123685 Exp 11/15 Lot# 02123695 Exp 11/15 Lot# 02123823 Exp 11/15 Lot# 02123833 Exp 11/15 Lot# 02123836 Exp 11/15 Lot# 02123853 Exp 11/15 Lot# 02123859 Exp 11/15 Lot# 02130021 Exp 12/15 Lot# 02130059 Exp 12/15 Lot# 02130079 Exp 12/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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