Atorvastatin Calcium Tablets recall: Sterility Concern
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.
Why was Atorvastatin Calcium Tablets recalled?
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, Exp 02/18; 3075566, 3075567, Exp 04/18; 3075890, 2007225, Exp 06/18; 2007340, Exp 08/18; 3079880, 3079881, Exp 10/18
- 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.
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 444,201 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- April 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)