Pravastatin Sodium Tablets Recalled for Failed Dissolution Specifications
Glenmark Pharmaceuticals is recalling Pravastatin Sodium 80mg tablets nationwide due to failed dissolution specifications. The affected tablets may not dissolve properly, potentially affecting drug absorption.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no illnesses or injuries reported. The hazard—dissolution failure that may reduce drug bioavailability—represents a risk-of-harm situation for patients dependent on statin therapy, meeting the rubric criterion for Score 3.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Pravastatin Sodium 80mg tablets distributed nationwide. The recall involves 90-count bottles (NDC 68462-198-90, 145,800 units) and 500-count bottles (NDC 68462-198-05, 1,368 units).
Affected batches failed to meet dissolution specifications, meaning the tablets may not dissolve properly and could be absorbed less effectively by the body. This affects the medication's ability to work as intended.
Consumers with the affected lot numbers should check with their pharmacy or healthcare provider. Refer to the FDA recall notice for the complete list of lot numbers and expiration dates involved in the recall.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Cardiovascular / Statin
- Hazard
- dissolution-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot#: a) 17211249
- 17211264
- 17211266
- 17211286
- Exp 6/30/24
- 17211525
- 17211535
- 17211549
- Exp 7/31/24
- 17211787
- 17211801
- 8/31/24
- 17212041
- 9/30/24
- 17212088
- 17212106
- Exp 10/31/24
- 17212346
- 17212345
- 11/30/24
UPCs (2)
- 0368462195901
- 0368462198902
Distribution
Distributed nationwide across the United States.
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