Drug Enforcement D-0643-2025

Presence of a foreign substance.

Status

Ongoing

Classification

Class II

Report Date

September 17, 2025

Termination Date

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Product Information

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
Product quantity
1512 cartons
Reason for recall
Presence of a foreign substance.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0643-2025
Event ID
97548
Recall initiation date
August 25, 2025
Center classification date
September 11, 2025
Code info
Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25
More code info
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