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
NAD+ Nicotinamide Adenine Dinucleotide
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Product found to be Sub Potent or Exceeded reconstitution time
What was recalled
NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835 NDC: 73198-0083-00
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0719-2022
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
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