The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0620-2017·Announced 2017-04-05

Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 40 mg tablets 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 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: The recall involves a high-risk hazard (microbial contamination with objectionable organisms) in a pharmaceutical product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling specific lots of Atorvastatin Calcium Tablets, 40 mg, in 90-count and 500-count bottles. The recall involves 444,201 bottles distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to microbial contamination of non-sterile products, specifically the potential for an elevated bioburden with the identification of objectionable organisms. The affected products are prescription-only medications.

Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, patients should stop using the medication and contact their healthcare provider or pharmacist for a replacement.

The recalled product

Product
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
444,201

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) 3073779
  • 3073780
  • Exp 02/18
  • 3074910
  • Exp 03/18
  • 3075568
  • Exp 04/18
  • 3075889
  • 3075890
  • Exp 06/18
  • 2007339
  • 2007340
  • Exp 08/18
  • 3079881
  • 3079882
  • Exp 10/18
  • b) 3070839
  • Exp 10/17
  • 3073778
  • 3073779

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 →

Related recalls

Same manufacturer · Mylan Pharmaceuticals Inc.

See all →

Same hazard · microbial contamination

See all →

Similar recalls