The Recall Desk
HighFDA (Drugs)·D-1100-2022·Announced 2022-06-15

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.

What this means for you

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
Hazard
  • temperature-abuse
  • cgmp-deviation

Distribution

Distributed nationwide across the United States.

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