Multi-event March 2022 FDA Recall Drug by Tmc Acquisition Llc Dba Tailor Made Compounding

This Multi-event Class II drug recall was voluntarily initiated by Tmc Acquisition Llc Dba Tailor Made Compounding on March 7, 2022 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 ongoing.

Reported Recall Events

D-1216-2022 ONGOING D-1194-2022 ONGOING D-1224-2022 ONGOING D-1217-2022 ONGOING D-1208-2022 ONGOING D-1197-2022 ONGOING D-1234-2022 ONGOING D-1221-2022 ONGOING D-1192-2022 ONGOING D-1222-2022 ONGOING D-1229-2022 ONGOING D-1226-2022 ONGOING D-1203-2022 ONGOING D-1212-2022 ONGOING D-1215-2022 ONGOING D-1195-2022 ONGOING D-1207-2022 ONGOING D-1204-2022 ONGOING D-1211-2022 ONGOING D-1196-2022 ONGOING D-1235-2022 ONGOING D-1206-2022 ONGOING D-1219-2022 ONGOING D-1243-2022 ONGOING D-1240-2022 ONGOING D-1214-2022 ONGOING D-1233-2022 ONGOING D-1218-2022 ONGOING D-1228-2022 ONGOING D-1225-2022 ONGOING D-1193-2022 ONGOING D-1220-2022 ONGOING D-1231-2022 ONGOING D-1205-2022 ONGOING D-1210-2022 ONGOING D-1223-2022 ONGOING D-1200-2022 ONGOING D-1238-2022 ONGOING D-1199-2022 ONGOING D-1201-2022 ONGOING D-1209-2022 ONGOING D-1213-2022 ONGOING D-1202-2022 ONGOING D-1242-2022 ONGOING D-1236-2022 ONGOING D-1239-2022 ONGOING D-1198-2022 ONGOING D-1241-2022 ONGOING D-1237-2022 ONGOING D-1227-2022 ONGOING D-1230-2022 ONGOING D-1232-2022 ONGOING

Recall Number: D-1216-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
191 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 10282106A1, Exp 4/26/2022; 11022118A1, Exp 4/30/2022; 12292115A1, Exp 6/27/2022; b)12082113A2, Exp 6/2/2022; 12292115A1, Exp 6/27/2022; 03072230A1, Exp 9/3/2022.

Recall Number: D-1194-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
39

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 10182113A1, Exp 4/16/2022.

Recall Number: D-1224-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
5,842 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 12032123A2, Exp 3/3/2022; 12102101A2, Exp 3/10/2022; 12202105A2, Exp 3/20/2022; 12292106A2, Exp 3/29/2022; 01062218B, Exp 4/6/2022; 01192228A2, Exp 4/19/2022; 01312214A2, Exp 5/1/2022; 02012211A1, Exp 5/2/2022; 02182201A1, 02182203A1, Exp 5/19/2022; 02242205A1, 02242206A1, Exp 5/25/2022; 03072209A1, Exp 6/5/2022; 03092203A1, 03092206A1, Exp 6/7/2022.

Recall Number: D-1217-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 03012234A1, Exp 8/28/2022.

Recall Number: D-1208-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
63 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 12222104A2, Exp 3/22/2022; 01032224A2, Exp 4/3/2022; 01282217A2, Exp 4/28/2022; 02192211A1; Exp 5/20/2022.

Recall Number: D-1197-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
39

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 12032113A2, Exp 6/1/2022; 01102206A1, Exp 7/9/2022.

Recall Number: D-1234-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
58 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : Expiry: a) 01142227A1, Exp 7/13/2022; b) 12012126A2, Exp 5/30/2022; 02042203A1, Exp 8/3/2022; c) 01052207A1, Exp 7/4/2022.

Recall Number: D-1221-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
220 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 11292109A2, Exp 5/28/2022, 01242202A1, Exp 6/18/2022; 03022214A1, Exp 8/29/2022.

Recall Number: D-1192-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
29 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

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

Recall Number: D-1222-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
58 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 10112102A2, Exp 4/9/2022; 11302101A1, Exp 5/29/2022; 01242201A1, Exp 5/31/2022.

Recall Number: D-1229-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
12 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 01132208A1, Exp 4/13/2022; 02252205A1, Exp 5/26/2022.

Recall Number: D-1226-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
1,208 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 10122103A2, Exp 3/22/2022; 11092108A2, Exp 4/30/2022; 11192115A2, Exp 5/7/2022; 12022107A2, Exp 5/22/2022; 12132107A2, Exp 5/24/2022; 01182201A2, Exp 6/30/2022; 02142212A1, Exp 8/13/2022; 03022217A1, Exp 8/29/2022.

Recall Number: D-1203-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
90 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 10122110A2, Exp 3/20/2022; 12062110A2, Exp 4/30/2022; 02012202A2, 02192207A1, Exp 7/31/2022.

Recall Number: D-1212-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
182 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 01072212A1, Exp 4/7/2022; 03032220A1, Exp 6/1/2022; b) 12162120A2, Exp 3/16/2022; 01142205A1, Exp 4/14/2022; 02012226A1, Exp 5/2/2022; 03032220A1, Exp 6/1/2022.

Recall Number: D-1215-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
652 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

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.

Recall Number: D-1195-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
657 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 02282223A1, Exp 8/27/2022; 10112101A2, Exp 4/9/2022; 11032108A1, Exp 4/30/2022; 11222101A2, Exp 5/21/2022; b) 01042234B, Exp 7/3/2022; 01242211A2, Exp 7/23/2022; 02282222A1, Exp 8/27/2022; 10112101A2, Exp 4/9/2022; 10182101A1, Exp 4/16/2022; 11162112A1, Exp 5/15/2022; 12062105A2, Exp 6/4/2022; 12142143A2, Exp 6/12/2022; 12202102A2, Exp 6/18/2022.

Recall Number: D-1207-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
294 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 01062225B, Exp 4/6/2022; 01142207A1, Exp 4/14/2022; 02012228A1, Exp 5/2/2022; 02032203A1, Exp 5/4/2022; 03012211A1, Exp 5/30/2022; 03082240A1, Exp 6/6/2022.

Recall Number: D-1204-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
60 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 10122105A2, Exp 3/20/2022; 01182216A1, Exp 5/31/2022; 02192207A1, Exp 7/31/2022; 03072206A1, Exp 9/3/2022.

Recall Number: D-1211-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
12 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 12022124A2, Exp 3/2/2022; 03032223A1, Exp 6/1/2022.

Recall Number: D-1196-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
180 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 11022106A1, Exp 4/30/2022; 11192106A2, Exp 5/18/2022; 12022105A1, Exp 5/31/2022; 12132108A1, Exp 6/11/2022; 12292117A1, Exp 6/27/2022.

Recall Number: D-1235-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
246 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 10202107A1, Exp 4/18/2022; b) 10142120A2, Exp 4/12/2022; 10272102A1, Exp 4/25/2022 ; 11032117A2, 11102104A2, Exp 4/30/2022; 01252212A2 , Exp 7/24/2022; 02182227A1, Exp 8/17/2022 .

Recall Number: D-1206-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
101 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 12172114A2, Exp 3/17/2022; 01142211A1, Exp 4/14/2022.

Recall Number: D-1219-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
1,856 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 10072110A2, 10142102A2, Exp 3/22/2022; 01112205A1, 11112123A1, Exp 4/30/2022; 11222114A1, 11172107A1, 11182120A2, Exp 5/7/2022; 01102207A1, 01122211A1, Exp 5/11/2022; 12162119A1, 12162121A1, Exp 5/24/20220; 02022223A2, Exp 6/30/2022; 03012204A1, Exp 8/23/2022; 03082249B, Exp 9/4/2022; 03092226B, 03092236B, Exp 9/5/2022.

Recall Number: D-1243-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
485 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 01122204A1, Exp 4/12/2022; 02192214A1, Exp 5/20/2022; b) 12142122A2, Exp. 3/14/2022; 12282118A2, Exp 3/28/2022; 01112203A1, Exp 4/11/2022; 01122208A1, Exp 4/12/2022; 01202211A2, Exp 4/20/2022; 02032205A1, Exp 5/4/2022; 02192212A1, Exp 5/20/2022; 03042201A1, Exp 6/2/2022.

Recall Number: D-1240-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
75 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 01252201A2, Exp 3/26/2022; b) 01252201A2, Exp 3/26/2022; 02032213A2, Exp 4/4/2022; 03042209A1, Exp 5/3/2022.

Recall Number: D-1214-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
232 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 12092105A2, exp 3/9/2022; 01042219A2, Exp 4/4/2022; 01202210A2, exp 4/20/2022; 01282207A1, exp 4/28/2022; 03032217A1, Exp 6/1/2022; 12092105A2; b) 01282207A1, Exp 4/28/2022; 03032241A1, Exp 6/1/2022

Recall Number: D-1233-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
106 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a)10142123A2, Exp 4/12/2022, 02042202A1, Exp 8/3/2022; b) 10142121A2, Exp 4/12/2022; 10202105A1, Exp 4/18/2022; 11102102A1, Exp 4/30/2022; 02042202A1, Exp 8/3/2022.

Recall Number: D-1218-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
464 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration 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.

Recall Number: D-1228-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
2,870 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 10122102A2, Exp 3/22/2022; 10252101A2, Exp 3/24/2022; 11092106A2, Exp 4/8/2022; 11232102A1, Exp 5/7/2022; 11162106A1, Exp 5/15/2022; 12032114A1, 02212224A1, Exp 5/22/2022; 12142111A1, 12202109A2, Exp 5/24/2022; 03032244A1, Exp 6/1/2022; 03082209A1, Exp 6/6/2022; 12292116A2, Exp 6/27/2022; 01182204A1, 01262232A1, 01262233A1, Exp 6/30/2022.

Recall Number: D-1225-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
9,993 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 12092115A2, Exp 3/9/2022; 12162116A2, Exp 3/16/2022; 12212106A2, Exp 3/21/2022; 01062219B, Exp 4/6/2022; 01072205A1, 01072208A1, Exp 4/7/2022; 01102203A1, Exp 4/10/2022; 01132207A1, Exp 4/13/2022; 01192216A1, Exp 4/19/2022; 01202204A2, Exp 4/20/2022; 01272223A2, Exp 4/27/2022; 01312219A2, Exp 5/1/2022; 02032204A2, Exp 5/4/2022; 02072203A1, Exp 5/8/2022; 02182216A1, 02182224A1, Exp 5/19/2022; 02232202A1, 02232210A1, Exp 5/24/2022; 02242202A1, 02242203A1, 02242235A1, 02242238A1, Exp 5/25/2022; 03072217A1, 03072223A1, Exp 6/5/2022; 03082223A1, 03082229A1, Exp 6/6/2022; 03092207A1, 03092219A1, Exp 6/7/2022.

Recall Number: D-1193-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
32 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 01042221A2, Exp 3/5/2022; 02192216A1, Exp 4/20/2022.

Recall Number: D-1220-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
243 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 10272107A1, Exp 4/25/2022; 12072130A1, Exp 6/5/2022; b) 01032230A1, Exp 7/2/2022.

Recall Number: D-1231-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
4,219 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a)12212105A2, Exp 6/19/2022; 02182229A1, Exp 8/17/2022; b) 12012121A2, Exp 5/30/2022; 12212104A2, Exp 6/19/2022; 01242216A2, Exp 7/23/2022; 02182236A1, Exp 8/17/2022; c) 12072133A1, Exp 6/5/2022; 01192225A1, Exp 7/18/2022; 02182228A1, Exp 8/17/2022; d)10142105A, Exp 4/12/2022; 10272105A1, Exp 4/25/2022; 11102101A1, 11032120A2, Exp 4/30/2022; 11222116A2, Exp 5/21/2022; 12012121A2, Exp 5/30/2022; 12072132A1, Exp 6/5/2022; 12152110A1, Exp 6/13/2022; 12162118A1, Exp 6/14/2022; 12212103A2, Exp 6/19/2022; 01052206A1, Exp 7/4/2022; 01142229A1, Exp 7/13/2022; 01212207A2 Exp, 7/20/2022; 02042201A1, Exp 8/3/2022; 02182226A1, Exp 8/17/2022; 02252224A1, 02252226A1, Exp 8/24/2022.

Recall Number: D-1205-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
40 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 12062113A2, Exp 3/6/2022; 01052209B, Exp 4/5/2022; 01312223A1, Exp 5/1/2022.

Recall Number: D-1210-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
25 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 01212203A2, Exp 4/21/2022; 02232213A1, Exp 5/24/2022.

Recall Number: D-1223-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
392 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 01042226A2, Exp 4/4/2022; 01242228A2, Exp 4/24/2022; 02212208A1, Exp 5/22/2022; b) 01192230A2, Exp 4/19/2022; 02212217A1, Exp 5/22/2022.

Recall Number: D-1200-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
84 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 01032234A2, Exp 7/2/2022; 02072212A1, Exp 8/6/2022.

Recall Number: D-1238-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
414 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a)10142117A2, Exp 4/12/2022; 10272108A1, Exp 4/25/2022; 11302113A2, Exp 5/29/2022; 02252220A1, Exp 8/24/2022; b)10142108A2, Exp 4/12/2022; 12072134A1, Exp 6/5/2022.

Recall Number: D-1199-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
19 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 01032232A1, Exp 7/2/2022; 01242229A2, Exp 7/23/2022.

Recall Number: D-1201-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
349 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 01052210A1, Exp 4/5/2022; 10202101A1, Exp 4/18/2022; 01052210A1 7/4/2022; b)10202102A1, Exp 4/18/2022; 12022126A1, Exp 5/31/2022; 01052210A1, Exp 7/4/2022.

Recall Number: D-1209-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
26 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 01032236A2, Exp 4/3/2022; 03072232A1, Exp 6/5/2022

Recall Number: D-1213-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
924 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 01172233A1, Exp 4/17/2022; 01282213A1, Exp 4/28/2022; 02192221A1, Exp 5/20/2022; b)12032118A2, Exp 3/3/2022; 12282120A2, Exp 3/28/2022 01172233A1, Exp 4/17/2022, 01282213A1, Exp 4/28/2022, 02212242A1, Exp 5/22/2022, 03042202A1, Exp 6/2/2022; c) 02192219A1, Exp 5/20/2022; 03062201A1, Exp 6/4/2022.

Recall Number: D-1202-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
45

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 10132102A2, Exp 3/22/2022; 01062221B, Exp 4/30/2022; 11302103A1, Exp 4/30/2022; 03032227A1, Exp 8/29/2022.

Recall Number: D-1242-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
15 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 02252201A1, Exp 4/15/2022.

Recall Number: D-1236-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
176 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a)11042102A1, Exp 4/30/2022; 12072135A1, Exp 6/5/2022, 01142228A1, Exp 7/13/2022; 02182231A1, Exp 8/17/2022; b)11042102A1, Exp 4/30/2022; 01142228A1, Exp 7/13/2022.

Recall Number: D-1239-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
64 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 12012123A2, Exp 5/30/2022; 01312212A1, Exp 7/30/2022.

Recall Number: D-1198-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
138 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 12072101A2, Exp 3/7/2022; 01042216A1, Exp 4/4/2022; 02142220A1, Exp 5/15/2022; b)12032129A2, Exp 3/3/2022; 02142220A1, Exp 5/15/2022; 03032213A1, Exp 6/1/2022; 03102214B, Exp 6/8/2022.

Recall Number: D-1241-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
6 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 03112233B, Exp 5/10/2022

Recall Number: D-1237-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
93 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

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

Recall Number: D-1227-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
1,562 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 11102107A2, Exp 4/9/202211232104A1, Exp 5/7/2022; 02212229A1, 11292103A2, Exp 5/22/2022; 12132105A2, Exp 5/24/2022; 02282207A1, Exp 5/29/2022; 03082209A1, Exp 6/6/2022; 03112231B, Exp 6/9/2022; 01042212A1, Exp 6/27/2022.

Recall Number: D-1230-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
273 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : a) 12212109A2, Exp 6/19/2022; 01312217A1, Exp 7/30/2022; b) 10202108A1, Exp 4/18/2022; 12012125A, Exp 5/30/2022 ;02182230A1, Exp 8/17/2022; 10202108A1; 03022222A1, Exp 8/29/2022.

Recall Number: D-1232-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
03-07-2022
Reported
07-20-2022
Quantity
41 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89909
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TMC Acquisition 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 USA and Puerto Rico
Product Description About Product Description
Full technical description of the product.
Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor Made Compounding

Batch or Lot Expiration Information

Batch# : 11232117A1, Exp 5/22/2022; 01312215A1, Exp 7/30/2022