Home / Recalls / TMC Acquisition LLC dba Tailor Made Compounding / D-1237-2022

D-1237-2022 Class II Ongoing

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

FDA drug recall D-1237-2022 was initiated by TMC Acquisition LLC dba Tailor Made Compounding on March 7, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 93 vials.

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: 93 vials

Product Description

Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Batch#: 11102106A1, Exp 4/30/2022; 01142230A1, Exp 7/13/2022.

Other recalls by TMC Acquisition LLC dba Tailor Made Compounding

D-1217-2022 Class II — Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor (March 7, 2022)
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D-1228-2022 Class II — Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compound (March 7, 2022)
D-1195-2022 Class II — Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made C (March 7, 2022)
D-1231-2022 Class II — Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, (March 7, 2022)
D-1230-2022 Class II — Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature (March 7, 2022)
D-1194-2022 Class II — Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Roo (March 7, 2022)
D-1208-2022 Class II — Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding (March 7, 2022)
D-1234-2022 Class II — Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 (March 7, 2022)
D-1216-2022 Class II — Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor (March 7, 2022)