The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0405-2023·Announced 2023-03-08

Accord Healthcare recalls Rosuvastatin tablets for manufacturing deviations

Accord Healthcare is recalling Rosuvastatin 10 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses or injuries 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 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 of a prescription medication due to manufacturing deviations. This constitutes a risk-of-harm product where injury has not yet been reported, but potential for adverse health consequences exists if deviations affected drug quality, potency, or safety.

Plain-English summary

Accord Healthcare, Inc. is recalling Rosuvastatin 10 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during a U.S. Food and Drug Administration inspection. The recall affects 56,862 bottles distributed across the United States, Puerto Rico, and Canada.

The affected product is packaged in 90-count and 1,000-count bottles. Multiple batch codes are included in this recall, with expiration dates ranging from August 2023 through July 2025.

No illnesses or injuries related to this recall have been reported. Patients currently taking recalled Rosuvastatin should contact their healthcare provider or pharmacist about their treatment options. Do not use the product after the expiration date printed on the bottle.

For questions or to report adverse effects, consumers and healthcare providers should contact Accord Healthcare, Inc. or the FDA.

The recalled product

Product
ROSUVASTATIN (ROSUVASTATIN)
Brand
ROSUVASTATIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
56,862

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) P2006824
  • Exp. Date 11/30/2023
  • P2102223
  • Exp. Date 3/31/2024
  • b) P2004949
  • Exp. Date 8/31/2023
  • P2004948
  • P2004950
  • P2004953
  • P2004954
  • P2004956
  • P2004955
  • P2004957
  • P2004958
  • P2004959
  • P2005252
  • Exp. Date 9/30/2023
  • P2006607
  • P2101368
  • Exp. Date 2/29/2024

UPCs (2)

  • 316729285155
  • 316729285179

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 →

Related recalls

Same brand · ROSUVASTATIN

Same manufacturer · Accord Healthcare, Inc.

See all →

Same hazard · manufacturing deviation

See all →

Similar recalls