Multi-event August 2022 FDA Recall Drug by Carolina Infusion

This Multi-event Class II drug recall was voluntarily initiated by Carolina Infusion on August 26, 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 completed.

Reported Recall Events

D-1524-2022 COMPLETED D-1533-2022 COMPLETED D-1522-2022 COMPLETED D-1528-2022 COMPLETED D-1519-2022 COMPLETED D-1523-2022 COMPLETED D-1525-2022 COMPLETED D-1527-2022 COMPLETED D-1529-2022 COMPLETED D-1530-2022 COMPLETED D-1526-2022 COMPLETED D-1532-2022 COMPLETED D-1534-2022 COMPLETED D-1521-2022 COMPLETED D-1516-2022 COMPLETED D-1531-2022 COMPLETED D-1520-2022 COMPLETED D-1517-2022 COMPLETED D-1518-2022 COMPLETED D-1515-2022 COMPLETED

Recall Number: D-1524-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
348 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 06012022@1, 06012022@2 BUD: 08/30/2022; 06032022@1, 06032022@2, 06032022@13 BUD: 09/01/2022; 06062022@7, BUD: 09/04/2022; 06072022@3, 06072022@4 BUD: 09/05/2022; 06082022@1, 06082022@2, 06082022@4 BUD: 09/06/2022; 06102022@8, BUD: 09/08/2022; 09/11/2022; 06132022@1, 06132022@7, 06132022@14, 06132022@15, BUD: 09/11/2022; 06142022@7, 06142022@8, 06142022@15, BUD: 09/12/2022; 06152022@2, BUD: 09/13/2022; 06172022@4, BUD: 09/15/2022; 06202022@9, 06202022@10, 06202022@23, BUD: 09/18/2022; 06212022@2, BUD: 09/19/2022; 06222022@2, 06222022@3, BUD: 09/20/2022; 06242022@4, 06242022@5, BUD: 09/22/2022; 06272022@3, BUD: 09/25/2022; 06292022@5, 06292022@6, BUD: 09/27/2022; 07012022@11, 07012022@12, BUD: 09/29/2022; 07052022@3, 07052022@4, BUD: 10/03/2022; 07062022@4, 07062022@5, 07062022@10, BUD: 10/04/2022;07082022@4, 07082022@5, BUD: 10/06/2022; 07092022@12, 07092022@13, BUD: 10/07/2022; 07112022@16, 07112022@17, BUD: 10/09/2022; 07122022@14, 07122022@15, BUD: 10/10/2022; 07132022@5, BUD: 10/11/2022; 07152022@11, 07152022@12, BUD: 10/13/2022; 07182022@2, 07182022@3, BUD: 10/16/2022; 07192022@10, 07192022@11, 07192022@22, BUD: 10/17/2022; 07202022@9, 07202022@10, 07202022@11, BUD: 10/18/2022; 07222022@2, BUD: 10/20/2022; 07252022@18, 07252022@19, BUD: 10/23/2022; 07272022@12, BUD: 10/25/2022; 07282022@5, BUD: 10/26/2022; 07292022@4, 07292022@5, BUD: 10/27/2022; 08012022@6, 08012022@7, BUD: 10/30/2022; 08022022@1, BUD: 10/31/2022; 08032022@8, 08032022@12, 08032022@13, BUD: 11/01/2022; 08052022@5, 08052022@6, BUD: 11/03/2022; 08082022@9, 08082022@15, 08082022@16, BUD: 11/06/2022; 08092022@10, 08092022@11, BUD: 11/07/2022; 08122022@5, 08122022@6, BUD: 11/10/2022; 08152022@16, 08152022@17, 08152022@20, BUD: 11/13/2022; 08192022@24, 08192022@5, 08192022@6, 08192022@25, BUD: 11/17/2022; 08222022@9, 08222022@10, BUD: 11/20/2022; 08232022@15, 08232022@18, BUD: 11/21/2022

Recall Number: D-1533-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lot: 08022022@12, BUD: 10/01/2022

Recall Number: D-1522-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 06132022@5 BUD: 09/11/2022; 08082022@17 BUD: 11/06/2022

Recall Number: D-1528-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 07052022@8, BUD: 09/03/2022; 07292022@10, BUD: 09/27/2022

Recall Number: D-1519-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
24 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 08122022@8 BUD: 09/11/2022; 08162022@3 BUD: 09/15/2022

Recall Number: D-1523-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 07182022@9 BUD: 10/16/2022; 07272022@15 BUD: 10/25/2022

Recall Number: D-1525-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lot: 07052022@1 BUD: 10/08/2022

Recall Number: D-1527-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
7 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 06272022@6 BUD: 08/26/2022; 07212022@3 BUD: 09/19/2022; 07292022@11 BUD: 09/27/2022; 08052022@7 BUD: 10/04/2022; 08102022@5 BUD: 10/09/2022; 08122022@14 BUD: 10/11/2022; 08172022@7 BUD: 10/16/2022

Recall Number: D-1529-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 07012022@6, BUD: 09/20/2022; 07192022@16, BUD: 09/17/2022; 07012022@4, BUD: 08/30/2022

Recall Number: D-1530-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
11 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 07052022@10, BUD: 09/03/2022; 07052022@16, BUD: 09/03/2022; 07122022@11, BUD: 09/08/2022; 07182022@17, BUD: 09/16/2022; 07202022@6, BUD: 09/18/2022; 07252022@9, BUD: 09/23/2022; 0729202222@2, BUD: 09/27/2022; 07292022@13, BUD: 09/27/2022; 08122022@9, BUD: 10/11/2022; 08162022@2, BUD: 10/15/2022; 082620222@1, BUD: 10/25/2022

Recall Number: D-1526-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
16 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 06282022@1, BUD: 08/27/2022; 06292022@8, BUD: 08/28/2022; 07012022@19, BUD: 08/30/2022; 07012022@3, BUD: 08/30/2022; 07122022@8, BUD: 09/10/2022; 07132022@9, BUD: 09/11/2022; 07192022@1, BUD: 09/17/2022; 07292022@9, BUD: 09/27/2022; 08032022@10, BUD: 10/02/2022; 08092022@2, BUD: 10/08/2022; 08102022@1, 08102022@6, 08102022@7, BUD: 10/09/2022; 08152022@5, BUD: 10/14/2022; 08192022@1, 08192022@10, BUD: 10/18/2022

Recall Number: D-1532-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lot: 07052022@2, BUD: 09/03/2022

Recall Number: D-1534-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lot: 08082022@3, BUD: 10/07/2022

Recall Number: D-1521-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
4 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lot: 08172022@1 BUD: 09/16/2022

Recall Number: D-1516-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
3 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 08012022@4 BUD: 01/28/2023; 08082022@12 BUD: 02/04/2023

Recall Number: D-1531-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 07152022@4, BUD: 09/13/2022; 08152022@15, BUD: 10/14/2022

Recall Number: D-1520-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
4 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lot: 08152022@14 BUD: 09/14/2022

Recall Number: D-1517-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
4 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 05042022@4 BUD: 10/31/2022; 062920222@9 BUD: 12/26/2022; 07262022@3 BUD: 01/22/2023

Recall Number: D-1518-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
8 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lots: 08012022@14 BUD: 08/31/2022; 08192022@7 BUD: 09/23/2022

Recall Number: D-1515-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-26-2022
Reported
09-21-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90798
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Carolina Infusion
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Batch or Lot Expiration Information

Lot# Lot: 06132022@17; BUD: 02/15/2023