The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0407-2023·Announced 2023-03-08

Rosuvastatin tablets recalled for manufacturing quality control deviations

Accord Healthcare is recalling rosuvastatin 40 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection. No illnesses have been 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: This is an FDA Class II recall for manufacturing practice deviations without any reported illnesses or injuries. Since no harm has been demonstrated and the hazard is theoretical, this qualifies as a precautionary recall with moderate severity.

Plain-English summary

Accord Healthcare, Inc. is recalling rosuvastatin calcium 40 mg tablets manufactured by Intas Pharmaceuticals Limited due to current good manufacturing practice (CGMP) deviations discovered during an FDA facility inspection.

The affected product was distributed in the United States, including Puerto Rico, and Canada. Approximately 102,360 bottles across multiple batch lots are included in this recall, with package sizes of 30-count, 90-count, and 1,000-count bottles. The affected batches have expiration dates ranging from December 2023 through August 2025.

No illnesses or injuries have been reported in connection with this recall. Patients currently taking this medication should consult their pharmacist or healthcare provider before making any changes to their treatment. Do not discontinue use without medical guidance.

The recalled product

Product
ROSUVASTATIN (ROSUVASTATIN)
Brand
ROSUVASTATIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Statin
Hazard
Affected units
102,360

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 (19)

  • Batches: a) P2100343
  • Exp. Date 12/31/2023
  • P2102371
  • Exp. Date 3/31/2024
  • b) P2101966
  • Exp. Date 2/28/2024
  • P2104545
  • Exp. Date 6/30/2024
  • P2204500
  • Exp. Date 7/31/2025
  • P2205415
  • Exp. Date 8/31/2025
  • c) P2101591
  • Exp. Date 2/28/2023
  • P2200062
  • Exp. Date 12/31/2024
  • P2204336
  • P2204337
  • P2205416

UPCs (3)

  • 316729287104
  • 316729287159
  • 316729287173

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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