The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0374-2023·Announced 2023-03-08

Atorvastatin Calcium 80 mg tablets recalled for manufacturing quality deviations

Accord Healthcare recalls Atorvastatin Calcium 80 mg tablets due to manufacturing process deviations identified during FDA inspection. 72,376 bottles were distributed in the US, Puerto Rico, and Canada.

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: This is an FDA Class II recall for manufacturing quality deviations without any reported illnesses or injuries. The recall represents a risk-of-harm situation due to manufacturing process failures, but the absence of reported adverse events places this at the High level rather than Severe.

Plain-English summary

Accord Healthcare, Inc. is recalling Atorvastatin Calcium Tablets USP 80 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recalled product includes tablets packaged as 90-tablet bottles (NDC 16729-047-15) and 500-tablet bottles (NDC 16729-047-16).

Current Good Manufacturing Practice (CGMP) standards regulate the processes and quality controls used in pharmaceutical manufacturing. The FDA identified deviations from these standards during an inspection.

72,376 bottles were distributed across the United States, including Puerto Rico and Canada. The affected batches include R2100283, R2100288, R2100289, R2200235, R2201037, R2200952, and others, with expiration dates ranging from February 2023 to June 2024.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
72,376

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)R2100283
  • R2100288
  • R2100289
  • Exp. Date 2/28/2023
  • R2200235
  • Exp. Date 1/31/2024
  • R2201037
  • R2200952
  • Exp. Date 6/30/2024
  • b) R2100291
  • R2100281
  • R2100282
  • R2100292
  • R2100293
  • R2100294
  • R2100290
  • R2100306
  • R2100348
  • R2100349
  • R2100347

UPCs (2)

  • 316729047159
  • 316729047166

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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