D-1218-2022 Class II Ongoing

Recalled by TMC Acquisition LLC dba Tailor Made Compounding — Nicholasville, KY

Recall Details

Product Type
Drugs
Report Date
July 20, 2022
Initiation Date
March 7, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
464 vials

Product Description

Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

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.