The Recall Desk
HighFDA (Drugs)·D-1066-2022·Announced 2022-06-15

Clonidine Hydrochloride Tablets Recalled Due to Temperature Abuse During Manufacturing

FDA recalls 63 bottles of Clonidine Hydrochloride Tablets (0.1 mg, NDC 00228-2127-10) distributed nationwide due to temperature abuse causing cGMP deviations during manufacturing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall without reported illnesses, hospitalizations, or injuries. Temperature abuse during manufacturing is a quality-control risk to drug efficacy, warranting High severity per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Clonidine Hydrochloride Tablets, USP, 0.1 mg (100-count bottles, manufactured by Teva/Actavis, NDC 00228-2127-10) are being recalled due to current good manufacturing practice (cGMP) deviations caused by temperature abuse. The product was distributed nationwide, affecting 63 bottles.

McKesson Medical-Surgical Inc., the recalling firm, issued this recall. The firm is unable to identify specific lot numbers for each customer but has distributed letters with the dates products may have been shipped.

Patients should contact their healthcare provider or pharmacist with questions about this recall and their medication.

The recalled product

Product
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG: Teva/Actavis, NDC 00228-2127-10
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug
Hazard
  • temperature-abuse
  • manufacturing-deviation

Distribution

Distributed nationwide across the United States.

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