Home / Recalls / UNICHEM PHARMACEUTICALS USA INC / D-1541-2022

D-1541-2022 Class III Terminated

Recalled by UNICHEM PHARMACEUTICALS USA INC — East Brunswick, NJ

Recall Details

Product Type
Drugs
Report Date
September 28, 2022
Initiation Date
September 19, 2022
Termination Date
March 2, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,960 bottles of 100

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

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,

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot # GCLH22005, exp. date 02/29/2024

Other recalls by UNICHEM PHARMACEUTICALS USA INC

  • D-0306-2026 Class III — Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by U (January 21, 2026)
  • D-0301-2026 Class II — Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-co (January 21, 2026)
  • D-0655-2025 Class I — Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, (August 27, 2025)
  • D-0255-2022 Class III — Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unic (October 25, 2021)
  • D-1291-2020 Class III — Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufact (May 26, 2020)
  • D-0829-2020 Class III — Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactu (January 29, 2020)
  • D-0228-2018 Class II — Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only (December 19, 2017)
  • D-0010-2018 Class II — Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: (October 2, 2017)
  • D-1519-2016 Class III — Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufa (August 19, 2016)
  • D-1352-2015 Class II — Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured (July 30, 2015)