UNICHEM PHARMACEUTICALS USA INC: Drug Recall

Recall #D-1541-2022 · 09/19/2022

Class III: Low Risk

Recall Details

Recall Number: D-1541-2022
Classification: Class III
Product Type: Drug
Recalling Firm: UNICHEM PHARMACEUTICALS USA INC
Status: Terminated
Date Initiated: 09/19/2022
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
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,

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

Distribution Pattern

Distributed Nationwide in the USA

Other Recalls by UNICHEM PHARMACEUTICALS USA INC

Class II: Risk 01/21/2026

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Class I: Dangerous 08/27/2025

Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Class III: Low Risk 10/25/2021

Discoloration

View all recalls by UNICHEM PHARMACEUTICALS USA INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.