Multi-event August 2023 FDA Recall Drug by Tmc Acquisitions Llc Dba Tailor Made Compounding

This Multi-event Class II drug recall was voluntarily initiated by Tmc Acquisitions Llc Dba Tailor Made Compounding on August 15, 2023 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1106-2023 TERMINATED D-1105-2023 TERMINATED

Recall Number: D-1106-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-15-2023
Reported
08-30-2023
Quantity
99 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92896
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisitions LLC dba Tailor Made Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2024
Product Description About Product Description
Full technical description of the product.
NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.

Batch or Lot Expiration Information

Lot# : 07192307A2, BUD: 11/18/2023

Recall Number: D-1105-2023

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-15-2023
Reported
08-30-2023
Quantity
9 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92896
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisitions LLC dba Tailor Made Compounding
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2024
Product Description About Product Description
Full technical description of the product.
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.

Batch or Lot Expiration Information

Lot# : 07262326A1, BUD: 10/24/2023