Recalls / Class II

Class IID-0795-2022

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

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

Olympia Compounding Pharmacy dba Olympia Pharmacy

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

6700 Conroy Rd Ste 155, Orlando, Florida 32835-3515

Distribution

Quantity

16,329 vials

Distribution pattern

Distributed Nationwide in the USA

Timeline

Recall initiated

2022-04-04

FDA classified

2022-04-27

Posted by FDA

2022-05-04

Terminated

2024-06-17

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0795-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.