The Recall Desk
ModerateFDA (Drugs)·D-0404-2023·Announced 2023-03-08

Rosuvastatin Tablets 5mg Recalled Due to Manufacturing Practice Deviations

Accord Healthcare is recalling Rosuvastatin tablets 5mg due to manufacturing practice deviations found during an FDA inspection. The recall involves 63,247 bottles distributed across the U.S., Puerto Rico, and Canada.

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: This is an FDA Class II recall for manufacturing practice deviations with no reported illnesses or injuries. The hazard is theoretical and precautionary, consistent with low-risk, voluntary recalls.

Plain-English summary

Rosuvastatin tablets 5mg, manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc., have been recalled due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection. The recall is classified as FDA Class II.

The affected product consists of 63,247 bottles distributed in the United States, including Puerto Rico, and Canada. Multiple batches are involved with expiration dates ranging from January 2024 through August 2025.

Consumers taking Rosuvastatin 5mg should check whether their medication is among the recalled batches by verifying the lot number and expiration date on their prescription bottle against the FDA's list of affected batches. Those with recalled medication should contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
ROSUVASTATIN (ROSUVASTATIN)
Brand
ROSUVASTATIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
63,247

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 (20)

  • Batches: a) P2101063
  • Exp. Date 1/31/2024
  • P2101707
  • Exp. Date 2/29/2024
  • P2203913 Exp. Date 6/30/2025
  • b) P2101064
  • P2101539
  • P2101709
  • P2102138
  • P2103186
  • Exp. Date 5/31/2024
  • P2104430
  • Exp. Date 6/30/2024
  • P2104703
  • Exp. Date 7/31/2024
  • P2104704
  • P2104705
  • P2104702
  • P2107176
  • Exp. Date 10/31/2024

UPCs (2)

  • 316729284158
  • 316729284172

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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