PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: September 17, 2025 Initiated: August 25, 2025 #D-0644-2025

Product Description

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.

Details

Recalling Firm
AvKARE
Units Affected
2003 cartons
Distribution
USA Nationwide
Location
Pulaski, TN

Frequently Asked Questions

What product was recalled?
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15. Recalled by AvKARE. Units affected: 2003 cartons.
Why was this product recalled?
Presence of a foreign substance.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 17, 2025. Severity: Moderate. Recall number: D-0644-2025.