Recalls / Class II

Class IID-1215-2022

Product

Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding

Affected lot / code info

Batch#: a)11092114A2, Exp 4/30/2022; 12172113A2, Exp 6/15/2022; 03072227A1, Exp 9/3/2022; b)10122101A2, Exp 4/10/2022; 12022116A1, Exp 5/31/2022; 12292115A1, Exp 6/27/2022; 02222207A1, Exp 8/21/2022; c)10112103A2, Exp 4/9/2022; 11192112A2, Exp 5/18/2022; 12142114A2, Exp 6/12/2022; 12202103A1, Exp 6/18/2022; 12282119A2, Exp 6/26/2022; 01192222A1, Exp 7/18/2022; 02232201A1, Exp 8/22/2022.

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

652 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-1215-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.