FDA Recalls Transderm Scop Scopolamine Transdermal Patches for Temperature Deviation
McKesson Medical-Surgical is recalling Transderm Scop (scopolamine) transdermal patches nationwide due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. No illnesses have been reported.
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 recall with no reported illnesses or adverse events. Temperature abuse during manufacturing is a cGMP deviation affecting a prescription drug product, but without reported harm, this represents a precautionary recall and qualifies as Moderate severity.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Transderm Scop (scopolamine) 1 mg/3 day transdermal patches nationwide. The recalled product comprises 56 cartons containing 10 patches each, indicated for prevention of motion sickness and post-operative nausea and vomiting (NDC 10019-553-03 and related package codes).
The recall is due to Current Good Manufacturing Practice (cGMP) deviations during manufacturing and distribution, specifically temperature abuse. Temperature exposure could affect the stability and efficacy of the scopolamine within the transdermal patch system. McKesson Medical-Surgical has notified all consignees but is unable to identify specific lot numbers for particular customers.
Healthcare providers and patients with this product should contact their supplier or McKesson Medical-Surgical for guidance. No illnesses or adverse events related to this product have been reported to the FDA. The FDA classifies this as a Class II recall.
The recalled product
- Product
- TRANSDERM SCOP (SCOPOLAMINE)
- Brand
- TRANSDERM SCOP
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Transdermal Patch
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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