FDA recall D-1128-2017

Mckesson Packaging Services · Class III · drug

Product

Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10

Reason for recall

Failed moisture limits: Out of specification for moisture content.

Distribution

PA, OH, IL, CO, LA

Key facts

Status: Terminated
Initiation date: 2017-08-28
Report date: 2017-09-13
Termination date: 2020-05-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Concord, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1128-2017