The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0719-2022·Announced 2022-03-30

FDA Recalls NAD+ Injection Due to Sub-Potency and Stability Concerns

Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide injection vials nationwide due to sub-potency or exceeded reconstitution time.

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: This is an FDA Class II recall for sub-potency and reconstitution/stability issues affecting a prescription drug. The rubric limits Class II recalls without hospitalization reports to High severity rather than Severe.

Plain-English summary

Olympia Compounding Pharmacy is recalling NAD+ Nicotinamide Adenine Dinucleotide lyophilized powder for injection due to sub-potency or exceeded reconstitution time. The recalled product is a multi-dose 500 mg vial formulation distributed nationwide, including Puerto Rico.

The affected lots are D24005 (expiration 4/5/22) and C41008 (expiration 3/8/22). A total of 2634 vials have been distributed. The product is dispensed by prescription only.

Sub-potency means the medication contains less active ingredient than labeled, which could affect treatment effectiveness. Exceeded reconstitution time may indicate the product does not remain stable after mixing with diluent.

If you have received this product, contact your healthcare provider or pharmacist for guidance. Do not use the recalled medication without first consulting a healthcare professional.

The recalled product

Product
NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia…
Affected units
2,634

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 (2)

  • Lot: D24005 Exp. 4/5/22
  • C41008 Exp. 3/8/22

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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