Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by…
Reason Cross contamination with other products.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Cross contamination with other products.
Reason Cross contamination with other products.
Reason Subpotent: Out of Specification for Assay Test at the 3-month time point.
Reason Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Reason Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
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