The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0618-2017·Announced 2017-04-05

Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 10 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 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, which corresponds to a Severe severity score under the rubric, particularly given the identification of objectionable organisms in a pharmaceutical product.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling specific lots of Atorvastatin Calcium Tablets, 10 mg, due to microbial contamination of non-sterile products. The recall is initiated because of the potential for an elevated bioburden with the identification of objectionable organisms.

The affected product is packaged in 90-count and 500-count bottles and is distributed nationwide in the USA and Puerto Rico. The recall covers 1,233,107 bottles across multiple lot numbers and expiration dates ranging from October 2017 to September 2018.

Consumers and healthcare providers should check their medication for the specific NDC codes and lot numbers listed in the official recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or healthcare provider for replacement or refund.

The recalled product

Product
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
1,233,107

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) 3076141
  • 3076142
  • Exp 05/18
  • 2007223
  • Exp 06/18
  • 2007335
  • Exp 07/18
  • 2007336
  • Exp 08/18
  • 2007446
  • 3084691
  • Exp 09/18
  • 3084692
  • Exp 01/18
  • b) 3073773
  • 2007445
  • c) 3076139
  • 3076140
  • 3076143
  • 3076144

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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