The Recall Desk
HighFDA (Drugs)·D-0422-2023·Announced 2023-03-08

Pravastatin Sodium tablets recalled for manufacturing practice violations

Accord Healthcare is recalling Pravastatin Sodium 20 mg tablets following an FDA inspection that identified manufacturing practice deviations. Approximately 32,688 bottles were 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: This is an FDA Class II recall involving manufacturing practice deviations found during an FDA inspection. While no illnesses or injuries have been reported, CGMP violations represent a real quality and safety risk in a pharmaceutical product requiring mandatory action.

Plain-English summary

Accord Healthcare, Inc. is recalling Pravastatin Sodium Tablets USP 20 mg in 90-count bottles due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection. The affected product has NDC 16729-009-15 and affected batch numbers are R2200589, R2200689, R2200690, and R2201232, all with an expiration date of April 30, 2024.

Approximately 32,688 bottles have been distributed in the United States, including Puerto Rico, and Canada. The product is manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, for Accord Healthcare, Inc., of Durham, North Carolina.

The FDA classifies this recall as a Class II recall. No illnesses or injuries related to the recalled tablets have been reported as of the time of this recall notice.

Patients taking these tablets should contact their pharmacy or healthcare provider for guidance regarding their treatment. Unused tablets should be properly disposed of through a pharmacy or following FDA disposal guidelines.

The recalled product

Product
PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Brand
PRAVASTATIN SODIUM
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Oral Tablet
Hazard
Affected units
32,688

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 (5)

  • Batches: a )R2200589
  • R2200689
  • R2200690
  • R2201232
  • Exp. Date 4/30/2024

UPCs (1)

  • 316729009157

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 →

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