The Recall Desk
ModerateFDA (Drugs)·D-1093-2022·Announced 2022-06-15

FDA Recalls Prazosin Hydrochloride Capsules Due to Temperature Storage Deviations

McKesson is recalling Prazosin Hydrochloride 1 mg capsules distributed nationwide due to temperature deviations during storage that may affect medication stability.

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 Class II FDA recall due to manufacturing process deviations (temperature abuse). No illnesses or injuries are mentioned in the recall notice, and the hazard is precautionary rather than based on confirmed product defect or harm.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Prazosin Hydrochloride Capsules, USP, 1 mg (Rx only) distributed nationwide due to temperature deviations that occurred during storage or transit. The temperature control deviations represent a deviation from current good manufacturing practice (cGMP) standards.

Temperature deviations during storage or handling may affect the stability and integrity of the medication. The affected product includes 100-count bottles with NDC code 0378-1101-01, manufactured by Mylan Pharmaceuticals Inc.

Patients who have received this medication should consult with their pharmacy or healthcare provider regarding whether their medication was affected by this recall.

The recalled product

Product
PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Brand
PRAZOSIN HYDROCHLORIDE
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Prescription
Hazard
  • temperature-abuse
  • manufacturing-deviation

Distribution

Distributed nationwide across the United States.

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