Drug product

NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00

D-0795-2022

April 04, 2022

Class II

Product summary

Firm: Olympia Compounding Pharmacy dba Olympia Pharmacy
Event: Event 89938
Status: Terminated
Classification: Class II
Quantity: 16,329 vials
Official record key: drug-enforcement:D-0795-2022

Official wording

Reason: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information: Lots: E24026 BUD: 5/26/2022, E42112 BUD: 5/12/2022, E48024 BUD: 2/2/2022, F24014 BUD: 6/14/2022, G48028 BUD: 7/28/2022, H24016 BUD: 8/16/2022, H42010 BUD 8/10/2022, H48030 BUD: 8/11/2022, I47003 BUD: 8/11/2022

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations