FDA recall D-0644-2025

AvKARE · Class II · drug

Product

chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15

Reason for recall

Presence of a foreign substance.

Distribution

USA Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-08-25
Report date: 2025-09-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0644-2025