Recalls / Class II

Class IID-1524-2022

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.

Affected lot / 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

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Carolina Infusion

Notification channel

E-Mail

Type

Voluntary: Firm initiated

Address

95 Bees Creek Rd, Ridgeland, South Carolina 29936-7540

Distribution

Quantity

348 vials

Distribution pattern

Nationwide in the USA.

Timeline

Recall initiated

2022-08-26

FDA classified

2022-09-15

Posted by FDA

2022-09-21

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-1524-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.