The Recall Desk
HighFDA (Drugs)·D-0372-2023·Announced 2023-03-08

Atorvastatin Calcium tablets recalled due to manufacturing practice deviations

Accord Healthcare is recalling Atorvastatin Calcium 20 mg tablets due to manufacturing practice deviations found during an FDA inspection. The affected products were 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: This is a FDA Class II recall for manufacturing practice deviations without reported illnesses or adverse events. The quality control risk to a prescription medication is substantial but remains theoretical in the absence of confirmed harm.

Plain-English summary

Accord Healthcare, Inc. is recalling approximately 241,585 bottles of Atorvastatin Calcium Tablets USP 20 mg in two package sizes (90-tablet and 1,000-tablet bottles). The medication was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India for Accord Healthcare, Inc., based in Durham, North Carolina.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection.

The affected products were distributed throughout the United States, including Puerto Rico and Canada. Multiple manufacturing batches are included in the recall, with expiration dates ranging from February 2023 to June 2024. Consumers taking this medication should contact their healthcare provider or pharmacist regarding this recall and should not discontinue use without consulting a healthcare professional.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
  • manufacturing-deviation

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)R2100305
  • Exp. Date 2/28/2023
  • R2200227
  • Exp. Date 1/31/2024
  • R2200797
  • Exp. Date 6/30/2024
  • b) R2101423
  • R2101438
  • R2101447
  • R2101446
  • Exp. Date 10/31/2023
  • R2200040
  • R2200041
  • R2200052
  • R2200043
  • R2200044
  • R2200051
  • R2200060
  • R2200061
  • R2200062

UPCs (2)

  • 316729045155
  • 316729045179

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · ATORVASTATIN CALCIUM

Same category