Recall Enforment Report D-1524-2022
- NDC List
- Drug Recall Enforcement Reports
- Recall Enforcement Report: 90798
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Carolina Infusion, originally initiated on 08-26-2022 for 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. The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently completed.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-1524-2022 | 08-26-2022 | 09-21-2022 | Class II | 348 vials | TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1533-2022 | 08-26-2022 | 09-21-2022 | Class II | 1 vial | QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1522-2022 | 08-26-2022 | 09-21-2022 | Class II | 2 vials | TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1528-2022 | 08-26-2022 | 09-21-2022 | Class II | 2 vials | TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1519-2022 | 08-26-2022 | 09-21-2022 | Class II | 24 syringes | Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1529-2022 | 08-26-2022 | 09-21-2022 | Class II | 3 vials | TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1530-2022 | 08-26-2022 | 09-21-2022 | Class II | 11 vials | TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1523-2022 | 08-26-2022 | 09-21-2022 | Class II | 3 vials | 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. | Lack of Assurance of Sterility | Completed |
D-1525-2022 | 08-26-2022 | 09-21-2022 | Class II | 1 vial | 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. | Lack of Assurance of Sterility | Completed |
D-1527-2022 | 08-26-2022 | 09-21-2022 | Class II | 7 vials | TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1532-2022 | 08-26-2022 | 09-21-2022 | Class II | 1 vial | TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1534-2022 | 08-26-2022 | 09-21-2022 | Class II | 1 vial | QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1526-2022 | 08-26-2022 | 09-21-2022 | Class II | 16 vials | TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1521-2022 | 08-26-2022 | 09-21-2022 | Class II | 4 syringes | Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1516-2022 | 08-26-2022 | 09-21-2022 | Class II | 3 vials | MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1531-2022 | 08-26-2022 | 09-21-2022 | Class II | 2 vials | TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1520-2022 | 08-26-2022 | 09-21-2022 | Class II | 4 syringes | Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1517-2022 | 08-26-2022 | 09-21-2022 | Class II | 4 vials | 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. | Lack of Assurance of Sterility | Completed |
D-1518-2022 | 08-26-2022 | 09-21-2022 | Class II | 8 syringes | Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
D-1515-2022 | 08-26-2022 | 09-21-2022 | Class II | 1 vial | L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed |
Recall Enforcement Report D-1524-2022
Field Name | Field Value |
---|---|
Event ID | 90798 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number | D-1524-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification | 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 What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
Distribution Pattern | Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
Product Description | TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. |
Reason For Recall | Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity | 348 vials Product Quantity The amount of product subject to recall. |
Voluntary Mandated | Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date | 09-21-2022 |
Recall Initiation Date | 08-26-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Initial Firm Notification | E-Mail Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type | Drugs |
Recalling Firm | Carolina Infusion |
Code Info | 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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Status | Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections. |