Tropicamide Ophthalmic Solution recalled for temperature abuse during manufacturing
McKesson Medical-Surgical is recalling Tropicamide Ophthalmic Solution, 1% USP, due to temperature control deviations during manufacturing. The recall affects 31 bottles distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II FDA recall involves manufacturing process deviations affecting a prescription medication. Temperature control violations could compromise drug potency and safety. No illnesses or injuries have been reported to date, but this meets the rubric criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tropicamide Ophthalmic Solution, USP 1%, a prescription eye medication manufactured by Sandoz Pharma and distributed by McKesson Medical-Surgical Inc., is being recalled because of temperature control deviations during manufacturing. These deviations represent violations of current Good Manufacturing Practice (cGMP) standards.
The recall involves 31 bottles that were distributed nationwide throughout the United States. McKesson is unable to identify the specific lot numbers for individual customers and has notified customers by letter with the distribution dates relevant to the recall so they can verify if they received affected product.
Customers who received this medication during the distribution dates specified in their recall notification letter should contact their pharmacy or eye care provider.
The recalled product
- Product
- Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131435502
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic
- Affected units
- 31
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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