The Recall Desk
HighFDA (Drugs)·D-0423-2023·Announced 2023-03-08

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
  • cgmp-violation

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

Distribution scope not specified by the agency.

Related recalls

Same brand · PRAVASTATIN SODIUM

Same category