Class II · Moderate risk
Pravastatin Sodium Tablets
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.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
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
Affected NDC
68462-0197-90
Compare with the code on your package — it is the most precise check available.
Drug: Pravastatin Category: Cholesterol Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pravastatin Sodium NDC 68462-0197 |
40 mg/1 | Tablet Oral |
Glenmark Pharmaceuticals Inc., USA | Rx |
- 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 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Pravastatin recalls
See all
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets 80mg
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
Failed Dissolution Specifications: results below specifications
Other recalls by Glenmark Generics Inc., USA
All 2013 recalls
Class II · Moderate risk
Ranitidine Tablets USP
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Class III · Low risk
Glenmark Topiramate Tablets
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Class III · Low risk
Glenmark Gabapentin Tablets
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
Class III · Low risk
Montelukast Sodium Tablets
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
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