September 2022 FDA Recall Clonidine Hydrochloride by Unichem Pharmaceuticals Usa Inc
D-1541-2022 - Product mix-up
This Class III drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc on September 19, 2022 for the product Clonidine Hydrochloride. The FDA reported the reason for recall as product mix-up. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1541-2022
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
09-19-2022
09-28-2022
18,960 bottles of 100
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
UNICHEM PHARMACEUTICALS USA INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA
03-02-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01
Batch or Lot Expiration Information
Lot# GCLH22005, exp. date 02/29/2024
