Recalls / Class II
Class IID-1218-2022
Product
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
- Affected lot / code info
- Batch #: a)11032122A2, Exp 4/30/2022; 01142226A1, Exp 7/13/2022; b)10272101A1, Exp 4/25/2022; 11292137A1, Exp 5/28/2022; 12142120A2, Exp 6/12/2022; 01042235B, Exp 7/3/2022; 01142226A1, Exp 7/13/2022; 03012240A1, Exp 8/28/2022; 03042223A1, Exp 8/31/2022.
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
- 464 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-1218-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.