Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination
Mylan Institutional, Inc. is recalling 1,527 cartons 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 and involves microbial contamination with objectionable organisms, which poses a significant health risk consistent with the 'Severe' criteria for significant injury or high-risk contamination.
Plain-English summary
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 1,527 cartons of Atorvastatin Calcium Tablets, 10 mg, 100-count Unit Dose Tablets. The product is identified by NDC 51079-208-20, Lot # 3084288, and an expiration date of 07/18. The recall was initiated because of microbial contamination of non-sterile products, specifically the potential for an elevated bioburden with the identification of objectionable organisms.
The affected products were distributed nationwide in the USA. This recall is classified as Class II by the U.S. Food and Drug Administration. Consumers and healthcare providers should stop using the affected lot of Atorvastatin Calcium tablets and contact their healthcare provider for alternative treatment options or to return the product to the pharmacy for a refund.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Category
- Drug — Prescription Drug
- Affected units
- 1,527
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 (2)
- Lot #: 3084288
- Exp. 07/18
Distribution
Distributed nationwide across the United States.
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