Naltrexone Hydrochloride tablets recalled due to manufacturing temperature control deviation
McKesson Medical-Surgical is recalling Naltrexone Hydrochloride 50 mg tablets distributed nationwide due to cGMP deviations related to temperature abuse during manufacturing.
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: FDA Class II recall with no reported illnesses, injuries, or adverse effects. This is a precautionary manufacturing quality control recall involving cGMP deviations and temperature abuse during production.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Naltrexone Hydrochloride Tablets, USP, 50 mg in 100-count bottles (NDC 0406-1170-03), manufactured by Mallinckrodt Inc. The recall was issued due to Current Good Manufacturing Practice (cGMP) deviations that occurred during manufacturing, specifically related to temperature control.
The recalled product was distributed nationwide throughout the United States. McKesson cannot identify which specific lot numbers were received by individual customers. However, notification letters sent to customers specify the date the product was distributed and the timeframe during which affected medication may have been shipped to them.
Customers and healthcare providers who received this product should refer to their notification letter from McKesson for specific instructions regarding product return or replacement.
The recalled product
- Product
- NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE)
- Brand
- NALTREXONE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0304061170017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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