February 2023 FDA Recall Drug by The Harvard Drug Group
D-0432-2023 - Packaging defect

This Class II drug recall was voluntarily initiated by The Harvard Drug Group on February 23, 2023 for the product Drug. The FDA reported the reason for recall as packaging defect. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0432-2023

Reason for Recall
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Initiated
02-23-2023
Reported
03-08-2023
Quantity
17,586 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91751
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-30-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot: M04145 Exp. 01/2024