Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason CGMP Deviations
Glenmark Pravastatin Sodium Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
What was recalled
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
- Recalling firm
- Glenmark Generics Inc., USA
- NDC code
- 68462-197-90
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-330-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Pravastatin recalls
See all
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets 80mg
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason Failed Dissolution Specifications: results below specifications
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