FDA recall D-0186-2020

Mylan Pharmaceuticals Inc. · Class II · drug

Product

Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05

Reason for recall

Presence of Foreign Substance

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2019-10-23
Report date
2019-11-13
Termination date
2020-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0186-2020