FDA recall D-1211-2018

Hetero Labs, Ltd. - Unit III · Class III · drug

Product

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90

Reason for recall

Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.

Distribution

Indiana and Louisiana

Key facts

Status: Terminated
Initiation date: 2018-09-12
Report date: 2018-10-03
Termination date: 2018-11-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hyderabad, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1211-2018