The Recall Desk
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.

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 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 Pharmaceutica
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • sub-potency
  • stability-issue

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.

Related recalls

Same category