Verapamil HCL injection recalled due to temperature abuse during manufacturing
McKesson Medical-Surgical is recalling Verapamil HCL injection ampules (NDC 04094-011-01) distributed nationwide due to temperature abuse during manufacturing.
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: FDA Class II classification confirms a manufacturing deviation, but no hospitalizations or reported illnesses have been documented. Temperature abuse of a drug presents a risk of compromised product efficacy, fitting the rubric criterion for High severity when injury has not yet been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Verapamil HCL 2.5 mg/mL injection ampules (NDC 04094-011-01) manufactured by Pfizer. The product was distributed nationwide in packs of five ampules.
The FDA classified this as a Class II recall due to current Good Manufacturing Practice (cGMP) deviations. The recalled ampules were exposed to temperature abuse during manufacturing.
Because McKesson was unable to identify the specific lot numbers received by individual consignees, each customer notification letter includes the distribution date and the dates the potentially impacted product may have been shipped to their facility. Healthcare providers should contact their supplier or McKesson Medical-Surgical with any questions about the recalled product.
The recalled product
- Product
- Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 04094-011-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable
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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