The Recall Desk
HighFDA (Drugs)·D-0619-2017·Announced 2017-04-05

Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg due to potential microbial contamination and elevated bioburden.

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: The recall involves a high-risk hazard (microbial contamination/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 Atorvastatin Calcium Tablets, 20 mg, 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 299,112 bottles across various lot numbers and expiration dates.

Consumers should stop using the recalled medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
299,112

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 (18)

  • Lot #: a) 3073776
  • Exp 01/18
  • 3073777
  • 3074909
  • Exp 02/18
  • 3075564
  • 3075565
  • Exp 03/18
  • 2007338
  • Exp 08/18
  • b) 3070838
  • Exp 10/17
  • 3073775
  • 3074908
  • 2007224
  • 3075887
  • Exp 06/18
  • 2007337

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.

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Same hazard · microbial contamination

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