Clonidine Hydrochloride
FDA Recall NDC 29300-135
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 3 recorded enforcement report(s) associated with Clonidine Hydrochloride (NDC 29300-135). A significant event, classified as Class III, was initiated on Sep 19, 2022 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Sep 19, 2022
Sep 28, 2022
18,960 bottles of 100
Recall Profile & Regulatory Data
Event ID
90709
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
UNICHEM PHARMACEUTICALS USA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Mar 02, 2023
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
Batch or Lot Expiration Information
Lot# GCLH22005, exp. date 02/29/2024
Affected Packages Involved in this Recall
29300-468-05Product
29300-468-10Product
29300-468-50Product
29300-468-01Product
29300-136-01Product
29300-136-05Product
29300-136-10Product
29300-136-50Product
29300-137-01Product
29300-137-05Product
29300-137-10Product
29300-137-25Product
29300-135-01Product
29300-135-05Product
29300-135-10Product
29300-135-50Product
Class III Terminated
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
May 26, 2020
Jun 17, 2020
190,992 bottles
Recall Profile & Regulatory Data
Event ID
85764
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
UNICHEM PHARMACEUTICALS USA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jan 08, 2021
Product Description
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, 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 29300-135-01
Batch or Lot Expiration Information
Lot# : GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021
Affected Packages Involved in this Recall
29300-468-05Product
29300-468-10Product
29300-468-50Product
29300-468-01Product
29300-136-01Product
29300-136-05Product
29300-136-10Product
29300-136-50Product
29300-137-01Product
29300-137-05Product
29300-137-10Product
29300-137-25Product
29300-135-01Product
29300-135-05Product
29300-135-10Product
29300-135-50Product
January 2020 Class III Recall: Failed Impurities/Degredation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
Jan 29, 2020
Feb 12, 2020
19161600 units
Recall Profile & Regulatory Data
Event ID
84836
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
UNICHEM PHARMACEUTICALS USA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Jan 08, 2021
Product Description
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, 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 29300-135-01
Batch or Lot Expiration Information
Lot# Lot Numbers: GCLL18108, GCLL18109, GCLL18110 - EXP 10/31/2020; GCLL19003 EXP 12/31/2020
Affected Packages Involved in this Recall
29300-468-05Product
29300-468-10Product
29300-468-50Product
29300-468-01Product
29300-136-01Product
29300-136-05Product
29300-136-10Product
29300-136-50Product
29300-137-01Product
29300-137-05Product
29300-137-10Product
29300-137-25Product
29300-135-01Product
29300-135-05Product
29300-135-10Product
29300-135-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
