Recalls / Class II
Class IID-1195-2022
Product
Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
- Affected lot / code info
- Batch #: a) 02282223A1, Exp 8/27/2022; 10112101A2, Exp 4/9/2022; 11032108A1, Exp 4/30/2022; 11222101A2, Exp 5/21/2022; b) 01042234B, Exp 7/3/2022; 01242211A2, Exp 7/23/2022; 02282222A1, Exp 8/27/2022; 10112101A2, Exp 4/9/2022; 10182101A1, Exp 4/16/2022; 11162112A1, Exp 5/15/2022; 12062105A2, Exp 6/4/2022; 12142143A2, Exp 6/12/2022; 12202102A2, Exp 6/18/2022.
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
- 657 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-1195-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.