The Recall Desk
HighFDA (Drugs)·D-1106-2023·Announced 2023-08-30

NAD+ Injectable Vials Recalled for Sterility Assurance Deficiency

NAD+ 200mg/ml vials from Tailor Made Compounding are recalled nationwide due to lack of assurance of sterility (Lot#07192307A2, BUD 11/18/2023). Consumers should discontinue use and consult their healthcare provider.

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 FDA Class II without reported illnesses or hospitalizations. The lack of sterility assurance in an injectable product presents risk of serious harm, but no injuries have been reported, fitting the 'risk-of-harm products where injury has not yet been reported' criterion for Score 3 (High).

Plain-English summary

Tailor Made Compounding (TMC Acquisitions LLC) has recalled NAD+ 200mg/ml injectable vials distributed nationwide. The product is supplied in 10ml vials with Lot#07192307A2 and expiration date 11/18/2023, with a total of 99 vials affected.

The recall is due to lack of assurance of sterility in the compounded drug vials. Sterility is critical for injectable products to prevent serious infections.

Consumers and healthcare providers who have received or possess vials from this lot should discontinue use immediately. Affected patients should contact their healthcare provider for guidance on appropriate alternatives. Healthcare providers, clinics, and pharmacies should verify receipt of product from this lot and remove it from circulation.

The recalled product

Product
NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
Manufacturer
TMC Acquisitions LLC dba Tailor Made Compounding
Hazard
  • sterility-defect
  • infection-risk

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#: 07192307A2
  • BUD: 11/18/2023

Distribution

Distributed nationwide across the United States.