FDA recall D-0622-2017

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class II · drug

Product

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.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2017-03-21
Report date: 2017-04-05
Termination date: 2019-03-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0622-2017