The Recall Desk
HighFDA (Drugs)·D-0373-2023·Announced 2023-03-08

Atorvastatin Calcium tablets recalled due to manufacturing practice deviations

Accord Healthcare is recalling 147,736 bottles of Atorvastatin Calcium 40 mg tablets due to manufacturing practice deviations discovered during an FDA inspection.

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: FDA Class II recall initiated following manufacturing practice deviations discovered during regulatory inspection. No reported illnesses or injuries, consistent with risk-of-harm classification where injury has not yet been reported.

Plain-English summary

Accord Healthcare, Inc. is recalling 147,736 bottles of Atorvastatin Calcium Tablets USP 40 mg distributed in the United States, Puerto Rico, and Canada. The affected product is available in two packaging configurations and multiple batch numbers with expiration dates ranging from April 2023 through September 2024.

The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations at the manufacturing facility. CGMP deviations relate to manufacturing and quality control procedures that ensure drug safety and quality.

Atorvastatin Calcium is a prescription medication. Patients who have been taking this medication and possess tablets from the affected batches should consult their healthcare provider.

Patients should not stop taking their medication without consulting their doctor. Consumers with questions should contact Accord Healthcare, Inc. or speak with their pharmacist or healthcare provider for guidance on alternative options and next steps.

The recalled product

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

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)R2100552
  • R2100553
  • Exp. Date 4/30/2023
  • R2200253
  • Exp. Date 2/29/2024
  • R2200627
  • Exp. Date 4/30/2024
  • R2201113
  • Exp. Date 6/30/2024
  • R2201184
  • Exp. Date 8/31/2024
  • R2201366
  • Exp. Date 9/30/2024
  • b) R2200280
  • R2200385
  • R2200386
  • R2200491
  • R2200490
  • R2200494
  • R2200496

UPCs (2)

  • 316729046152
  • 316729046176

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · ATORVASTATIN CALCIUM

Same category