← FDA ENFORCEMENT
D-0643-2025Class II

AvKARE

Recalling firm
AvKARE
Product type
Drug
Status
Ongoing
Report date
2025-09-17
Distribution
USA Nationwide
Firm state
TN
Product quantity
1512 cartons
Initiated by
Voluntary: Firm initiated
Reason for recall

Presence of a foreign substance.

Product description

chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15

Code / lot info

Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.