FDA Recalls Pravastatin Sodium Tablets Due to Manufacturing Deviations
Accord Healthcare is recalling Pravastatin Sodium Tablets USP 40 mg due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 120 bottles distributed in the United States, Puerto Rico, and Canada.
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: FDA Class II recall for manufacturing compliance deviations. No illnesses or injuries have been reported. The hazard is potential, based on manufacturing process defects, meeting the High severity threshold as a risk-of-harm product without documented injury.
Plain-English summary
Accord Healthcare, Inc. is recalling Pravastatin Sodium Tablets USP, 40 mg, due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recalled product was distributed in the United States, including Puerto Rico and Canada.
The affected product consists of 120 bottles with batch number R2201294, expiration date August 31, 2025, and NDC 16729-010-17. The medication was manufactured by Intas Pharmaceuticals Limited, Ahmedabad, India.
Patients taking pravastatin should consult their healthcare provider for guidance regarding their medication.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- Affected units
- 120
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 (2)
- Batches: R2201294
- Exp. Date 8/31/2025
UPCs (1)
- 316729010177
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 67 recalled by Accord Healthcare, Inc. 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.
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