Mylan Amiodarone Hydrochloride Injection Recalled for Temperature Abuse
Mylan Institutional LLC is recalling Amiodarone HCl Injection due to inadvertent refrigeration during distribution. McKesson distributed the affected vials to facilities in WA, OR, and MT.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may or is likely to cause temporary or medically reversible adverse health consequences. The hazard is a storage deviation (temperature abuse) rather than a confirmed contamination or defect, and no illnesses or injuries are reported in the source text.
Plain-English summary
Mylan Institutional LLC is recalling Amiodarone Hydrochloride Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vials. The recall is due to a temperature abuse incident where one shipment was inadvertently stored refrigerated rather than at the labeled room temperature recommendation. This occurred at McKesson Medical-Surgical Inc., a distributing wholesaler.
The affected product is identified by Lot #140502 with an expiration date of 10/31/2015. McKesson Medical-Surgical Inc. distributed the product to six physicians and/or medical facilities located in Washington, Oregon, and Montana.
Healthcare providers and facilities should check their inventory for this specific lot number and discontinue use if found. Patients who have received this medication should contact their healthcare provider for guidance.
The recalled product
- Product
- AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
- Brand
- AMIODARONE HYDROCHLORIDE
- Manufacturer
- Mckesson
- Category
- Drug — Injection
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #140502
- Exp 10/31/2015
Distribution
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