Class II · Moderate risk Terminated
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Mannitol 5% Injectable
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
What was recalled
Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Recalling firm
- The Compounding Pharmacy of America
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1566-2015
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.
Other Mannitol recalls
See all
Class II · Moderate risk Terminated
Cardioplegia Solution del Nido Formula
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
Cardioplegia Solution del Nido Formula
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class III · Low risk Terminated
Netspot
Reason Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Class II · Moderate risk Terminated
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Reason Super Potent and Failed Reconstitution Time
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.