Agency classClass IIOur severity:High FDA (Drugs)·D-0939-2022·Announced 2022-06-01

FDA recalls NAD+ pharmaceutical powder vials due to sterility concerns

Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide powder vials nationwide due to lack of assurance of sterility. The recall affects 8,982 vials distributed across the USA, Puerto Rico, and US Virgin Islands.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall with no reported illnesses or injuries. The hazard (lack of sterility assurance) is theoretical without confirmed contamination or adverse health effects, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide lyophilized powder for reconstitution. The recalled product is supplied in multi-dose 500 mg vials marked as Rx Only. A total of 8,982 vials have been distributed.

The recall was initiated due to lack of assurance of sterility. Sterility is critical for injectable pharmaceutical preparations. The affected lots are: A2401422 (BUD 1/14/2023), K41001 (BUD 11/1/2022), K41130 (BUD 11/30/2022), L24113 (BUD 12/13/2022), and L41102 (BUD 12/2/2022).

The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands. Healthcare providers and patients who have received this product should cease use and contact their pharmacy or healthcare provider for guidance. Do not use any remaining doses from affected lots.

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: contamination-risk
Affected units: 8,982

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 (5)

Lots: A2401422 BUD: 1/14/2023
K41001 BUD: 11/1/2022
K41130 BUD: 11/30/2022
L24113 BUD: 12/13/2022
L41102 BUD: 12/2/2022

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 53 products in this recall →

Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy

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