Recalls / Class II
Class IID-1219-2022
Product
NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
- Affected lot / code info
- 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; 03082249B, Exp 9/4/2022; 03092226B, 03092236B, Exp 9/5/2022.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Moore Dr, Nicholasville, Kentucky 40356-8512
Distribution
- Quantity
- 1,856 vials
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2022-03-07
- FDA classified
- 2022-07-14
- Posted by FDA
- 2022-07-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1219-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.