Drug Enforcement 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,

1 Views

Status

Terminated

Classification

Class III

Report Date

September 28, 2022

Termination Date

March 2, 2023

Product Information

Product description
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
Product quantity
18,960 bottles of 100
Reason for recall
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed Nationwide in the USA

Location & Firm

Recalling firm
Unichem Pharmaceuticals Usa Inc
Address
1 Tower Center Blvd Ste 2200, N/A

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

Codes & Dates

Recall number
D-1541-2022
Event ID
90709
Recall initiation date
September 19, 2022
Center classification date
September 22, 2022
Code info
Lot # GCLH22005, exp. date 02/29/2024
More code info
—