Topex Benzocaine Topical Anesthetic Recalled for Temperature-Abuse Manufacturing Deviation
McKesson Medical-Surgical is recalling Topex benzocaine 20% topical anesthetic gel due to cGMP deviations involving temperature abuse during manufacturing. The recall affects 24 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 is an FDA Class II recall for manufacturing deviations (temperature abuse during production). Although no illnesses or injuries are reported in the source text, temperature-compromised pharmaceutical products represent a risk-of-harm category; the score reflects this theoretical risk in the absence of reported actual injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Topex (benzocaine 20%) Topical Anesthetic Gel Strawberry, 1 oz bottles (NDC 0699-5116-01), an Rx-only topical anesthetic manufactured by DS Healthcare. The recall affects 24 bottles distributed nationwide across the United States.
The recall was initiated due to cGMP deviations identified during manufacturing, specifically temperature-abuse conditions. McKesson Medical-Surgical was unable to identify the specific lot number received by individual customers. Customers received notification letters that included the date the product was distributed and the dates during which the affected product may have been shipped to them.
Customers and healthcare providers who possess the recalled product should discontinue use and contact McKesson Medical-Surgical or DS Healthcare for instructions on return or replacement.
The recalled product
- Product
- Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Topical Anesthetic
- Affected units
- 24
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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