The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0421-2023·Announced 2023-03-08

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
9,600

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

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.

See all 67 products in this recall →

Related recalls

Same brand · PRAVASTATIN SODIUM

Same manufacturer · Accord Healthcare, Inc.

See all →

Same hazard · cgmp deviation

See all →

Similar recalls