The Recall Desk
ModerateFDA (Drugs)·D-1091-2022·Announced 2022-06-15

Duraclon Injectable Drug Recalled for Temperature-Related Manufacturing Deviations

McKesson is recalling 9 vials of Duraclon (clonidine HCl) injection nationwide due to temperature deviations that violated current Good Manufacturing Practice (cGMP) standards.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary, precautionary FDA Class II recall triggered by manufacturing control deviations related to temperature exposure. No illnesses, injuries, or adverse events have been reported, classifying this as a quality-control issue affecting drug stability rather than confirmed contamination or direct toxicity.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling 9 vials of Duraclon (clonidine HCl injection, USP) 1000 mcg/10 mL for epidural injection. The product was manufactured by Mylan Pharma and distributed nationally.

The recall is due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse of the product. Temperature exposure during storage or distribution can affect the stability and quality of injectable medications.

Customers who received this product should contact McKesson regarding their shipments. The distributor notes it is unable to identify the specific lot numbers associated with individual customers based on distribution records. Healthcare providers should quarantine affected vials and verify their inventory against distribution dates provided in recall communications.

The recalled product

Product
DURACLON (CLONIDINE HYDROCHLORIDE)
Brand
DURACLON
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable Medication
Hazard
  • temperature-abuse
  • manufacturing-deviation

Distribution

Distributed nationwide across the United States.

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