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Recall Observatory FDA recall evidence

Drug product

Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

D-0468-2019

December 17, 2018

Class II

Product summary

Firm
Promise Pharmacy, LLC
Event
Event 81810
Status
Terminated
Classification
Class II
Quantity
5 10 mL vials
Official record key
drug-enforcement:D-0468-2019

Official wording

Reason: Lack of sterility assurance.

Code information: Lots: 11062018@13 BUD: 12/21/2018; 11072018@24 BUD: 12/22/2018

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility