Pravastatin Sodium Tablets Recalled Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Pravastatin Sodium 10 mg tablets for CGMP deviations found during FDA inspection. About 9,600 bottles were distributed across the United States, Puerto Rico, and Canada. No illnesses reported.
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: FDA Class II recall for manufacturing practice deviations with no reported illnesses or identified specific contamination. Without a named hazard or reported injury, this manufacturing-based recall corresponds to Moderate severity under the rubric.
Plain-English summary
Accord Healthcare, Inc. is recalling Pravastatin Sodium 10 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during a recent FDA inspection. The product was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India.
The recall affects approximately 9,600 bottles distributed in the United States, Puerto Rico, and Canada. The affected batches are R2201093, R2201222, and R2201231, all expiring on 4/30/2024. Both 90-count and 500-count bottles are included.
No illnesses or injuries have been reported in connection with this product. The FDA classified this as a Class II recall based on manufacturing deviations discovered during inspection.
Consumers with affected bottles should contact their pharmacist or physician for guidance.
The recalled product
- Product
- PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
- Brand
- PRAVASTATIN SODIUM
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- cgmp-deviation
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 (4)
- Batches: a) R2201093
- Exp. Date 4/30/2024
- b) R2201222
- R2201231
UPCs (2)
- 316729008150
- 316729008167
Distribution
Distribution scope not specified by the agency.
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