The Recall Desk
HighFDA (Drugs)·D-1219-2022·Announced 2022-07-20

NAD+ Injectable Vials Recalled Due to Lack of Sterility Assurance

Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL because the company cannot assure the product meets sterility requirements. The affected vials were distributed nationwide to the United States and Puerto Rico.

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 lack of sterility assurance in an injectable product. Although no illnesses or injuries have been reported, the potential risk of infection from non-sterile injectable medication represents a significant harm risk fitting the criterion 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL (a 10mL-per-vial injectable product) distributed nationwide to the United States and Puerto Rico. The recall affects multiple batches with expiration dates ranging from March 2022 to September 2022.

The recall is being conducted because the company cannot assure that the product meets sterility requirements. Lack of adequate sterility assurance in injectable medications poses a potential risk of infection for patients who receive the affected product.

Healthcare providers and patients who may have received doses from the affected batches should discontinue use immediately. If you have questions, contact Tailor Made Compounding or your healthcare provider. Patients who have already received injections from recalled vials should consult their healthcare provider to discuss any potential health concerns.

The recalled product

Product
NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Manufacturer
TMC Acquisition LLC dba Tailor Made Compounding
Category
Drug — Injectable
Hazard
  • lack-of-sterility
  • 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 (20)

  • Batch#: 10072110A2
  • 10142102A2
  • Exp 3/22/2022
  • 01112205A1
  • 11112123A1
  • Exp 4/30/2022
  • 11222114A1
  • 11172107A1
  • 11182120A2
  • Exp 5/7/2022
  • 01102207A1
  • 01122211A1
  • Exp 5/11/2022
  • 12162119A1
  • 12162121A1
  • Exp 5/24/20220
  • 02022223A2
  • Exp 6/30/2022
  • 03012204A1
  • Exp 8/23/2022

Distribution

Distributed nationwide across the United States.

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