The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0424-2023·Announced 2023-03-08

Pravastatin Sodium 80 mg tablets recalled for manufacturing deviations

Accord Healthcare is recalling Pravastatin Sodium 80 mg tablets due to manufacturing process deviations discovered during an FDA inspection. The recall affects approximately 1,970 bottles distributed in the United States, Puerto Rico, and Canada.

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 3/5 (High).

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 without reported illnesses, injuries, or hospitalizations. The hazard—manufacturing process deviations identified during an FDA inspection—is regulatory and theoretical rather than manifested in patient harm. Per the rubric, theoretical hazards without reported illness score at most 3 (High).

Plain-English summary

Accord Healthcare, Inc. is recalling Pravastatin Sodium 80 mg tablets USP (NDC 16729-011-15, UPC 316729011150) in 90-count bottles. The product was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India.

The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations. These deviations represent failures to maintain proper quality standards and controls during drug manufacturing.

The affected batch is R2201233 with an expiration date of 4/30/2024. Approximately 1,970 bottles were distributed throughout the United States, Puerto Rico, and Canada.

Patients with Pravastatin Sodium from the affected batch should contact their pharmacy or healthcare provider to verify whether their medication is from the recalled batch. Check the NDC number (16729-011-15) and batch/expiration date printed on the bottle.

The recalled product

Product
PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Brand
PRAVASTATIN SODIUM
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
1,970

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: R2201233
  • Exp. Date 4/30/2024

UPCs (1)

  • 316729011150

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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