The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0621-2017·Announced 2017-04-05

Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets, 80 mg, due to potential microbial contamination and elevated bioburden.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination with objectionable organisms, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant health impact).

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Atorvastatin Calcium Tablets, 80 mg, packaged in 90-count and 500-count bottles. The recall is due to microbial contamination of non-sterile products, specifically the potential for an elevated bioburden with the identification of objectionable organisms.

The affected product is prescription-only and was distributed nationwide in the USA and Puerto Rico. The recall involves 452,269 bottles across multiple lot numbers and expiration dates ranging from October 2017 to October 2018.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions or to obtain a replacement.

The recalled product

Product
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
452,269

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)

  • Lot #: a) 3073782
  • 3073783
  • Exp 02/18
  • 3074915
  • 3074916
  • 3074917
  • Exp 03/18
  • 3074918
  • 3075572
  • Exp 04/18
  • 3075573
  • 3075574
  • Exp 05/18
  • 2007226
  • 3075894
  • Exp 06/18
  • 2007344
  • 2007345
  • 2007346
  • Exp 08/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Mylan Pharmaceuticals 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 4 products in this recall →

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