FDA Recalls MIOSTAT Carbachol Solution Nationwide for Temperature Abuse
McKesson Medical-Surgical is recalling MIOSTAT (Carbachol Intraocular Solution) nationwide due to temperature abuse during distribution that may affect medication stability.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 classification indicates potential for adverse health consequences, but this temperature-abuse manufacturing deviation lacks reported illnesses or injuries, meeting the threshold for moderate severity as a precautionary pharmaceutical recall.
Plain-English summary
MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, a prescription eye medication manufactured by Alcon Surgical Inc. and distributed by McKesson Medical-Surgical Inc., is being recalled nationwide due to cGMP deviations involving temperature abuse.
The temperature exposure occurred during product distribution and may have compromised the stability of the medication. The recall includes 8 boxes containing 12 vials each (1.5 mL vials), NDC 0065-0023-15, which were distributed across the United States.
McKesson Medical-Surgical Inc. has notified customers and provided information regarding which product lots may have been affected based on the dates the medication was shipped to individual facilities.
The recalled product
- Product
- MIOSTAT (CARBACHOL)
- Brand
- MIOSTAT
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
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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