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D-1192-2022 Class II Ongoing

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

FDA drug recall D-1192-2022 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: 29 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: 29 vials

Product Description

Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Batch #: 12082102A2, Exp 3/8/2022; 02212201A1, Exp 5/22/2022.

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)
D-1215-2022 Class II — Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temper (March 7, 2022)
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-1237-2022 Class II — Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made (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-1216-2022 Class II — Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor (March 7, 2022)