Drug Enforcement D-0432-2023

Packaging defect: observed packaging defect, blister packaging inadequately sealed.

Status

Terminated

Classification

Class II

Report Date

March 8, 2023

Termination Date

April 30, 2024

Product Information

Product description
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4
Product quantity
17,586 cartons
Reason for recall
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Distributed Nationwide in the USA

Location & Firm

Recalling firm
The Harvard Drug Group
Address
341 Mason Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0432-2023
Event ID
91751
Recall initiation date
February 23, 2023
Center classification date
March 2, 2023
Code info
Lot: M04145 Exp. 01/2024
More code info
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