Glenmark Recalls Pravastatin Sodium Tablets Due to Off-Odor Complaints
Glenmark Generics is recalling Pravastatin Sodium 40 mg tablets due to reports of a moldy, musty, or fishy odor.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is limited to an off-odor complaint without reported illness or injury, fitting the criteria for a moderate severity score.
Plain-English summary
Glenmark Generics Inc., USA is recalling Pravastatin Sodium Tablets, 40 mg, 90-count bottles (NDC 68462-197-90). The recall is being conducted due to complaints regarding an off-odor described as moldy, musty, or fishy in nature.
The affected product is a prescription-only medication manufactured by Glenmark Generics Ltd. in India and distributed nationwide. The recall covers 246,528 bottles across multiple lot numbers with expiration dates ranging from March 2015 to December 2015.
Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, patients should stop using it and consult their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Glenmark Generics Inc., USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 246,528
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (2)
- 0368462195901
- 0368462198902
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Glenmark Generics Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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