The Recall Desk
HighFDA (Drugs)·D-0795-2022·Announced 2022-05-04

NAD+ Compounded Drug Recall for Manufacturing Quality Control Violations

Olympia Compounding Pharmacy is recalling NAD+ lyophilized powder (16,329 vials nationwide) due to failure to properly investigate environmental and personnel monitoring violations in manufacturing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a compounded injectable drug with CGMP violations involving failure to properly investigate environmental monitoring for a sterile product. No illnesses or injuries have been reported, and the hazard is theoretical. This meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide lyophilized powder for reconstitution due to Current Good Manufacturing Practice (CGMP) deviations. Prior to October 1, 2021, the facility failed to properly investigate environmental and personnel monitoring Out of Action Limit (OOAL) excursions.

The affected product is a 500 mg per vial, multi-dose injectable powder distributed nationwide across the United States. This recall affects 16,329 vials with lot codes E24026, E42112, E48024, F24014, G48028, H24016, H42010, H48030, and I47003, each with corresponding Beyond Use Dates ranging from February 2022 through August 2022.

Patients who received this product should contact their physician or pharmacist to discuss this recall.

The recalled product

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
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • cgmp-violation
  • monitoring-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category