Triamcinolone Acetonide Cream Recalled Due to Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Triamcinolone Acetonide cream nationwide due to cGMP deviations related to temperature abuse during manufacturing. Specific lot numbers of affected product could not be identified.
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 cGMP deviations involving temperature abuse during manufacturing. No illnesses, injuries, or deaths are reported in the source text. Per the severity rubric, FDA Class II recalls without reported hospitalizations and with theoretical hazards score as Moderate (2).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Triamcinolone Acetonide cream, USP 0.1%, supplied in 15-gram tubes. Approximately 30 tubes were distributed nationwide. This is a prescription corticosteroid cream.
The recall was initiated due to cGMP deviations related to temperature abuse during manufacturing. Temperature control was not properly maintained during the manufacturing process.
McKesson Medical-Surgical was unable to identify specific lot numbers affected by this issue. Customers received notification letters indicating the distribution dates of potentially impacted product.
The recalled product
- Product
- TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
- Brand
- TRIAMCINOLONE ACETONIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (3)
- 0301680004150
- 0301680003153
- 0301680002156
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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