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FDA (Drug enforcement)Recalled 2022-04-13closedclass ii

Mckesson Medical-Surgical Inc. Corporate Office: Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10

Is my product affected?

Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10

  • Brand DURACLON

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical is recalling Duraclon (clonidine HCl injection, USP) 1000 mcg/10 mL vials manufactured by Mylan Pharma due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse. The recalled product was distributed nationwide in the USA, and nine vials are affected. Because McKesson is unable to identify which specific lot numbers were received by individual customers, each notification letter includes the distribution date to customers and the dates when impacted product may have been shipped.

The source document does not specify a remedy or instructions for affected consumers regarding what action they should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cGMP deviations: Temperature abuse

Details from the source

Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 9 vials Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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