PlainRecalls
FDA Drug Moderate Class II Terminated

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20

Reported: April 5, 2017 Initiated: March 21, 2017 #D-0622-2017

Product Description

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20

Reason for Recall

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

Details

Units Affected
1,527 cartons
Distribution
Nationwide in the USA
Location
Rockford, IL

Frequently Asked Questions

What product was recalled?
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 1,527 cartons.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 5, 2017. Severity: Moderate. Recall number: D-0622-2017.