Verapamil Injection Is Recalled Over Sterility Assurance Concerns
FDA is recalling Verapamil Injection compounded by Pallimed Solutions Pharmacy because inspectional findings raised concerns about quality-control procedures and sterility assurance. The recall covers all lots within expiry 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: The source identifies an FDA Class II recall involving a sterility-assurance risk, but it does not report hospitalization or other injury. This meets the rubric's High criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
FDA is recalling Verapamil Injection compounded by Pallimed Solutions Pharmacy in Woburn, Massachusetts. The recall covers all lots within expiry distributed nationwide.
FDA inspectional findings raised concerns about quality-control procedures that impacted sterility assurance. The source does not provide specific consumer instructions.
The recalled product
- Product
- Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Sterility assurance
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Pallimed Solutions 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.
See all 25 products in this recall →Related recalls
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