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Class II: temporary or reversible health riskCompleted

Carolina Infusion Test Cyp/Dhea Recall

TEST CYP/DHEA (Sesame) 200 MG/2

Carolina Infusion · Ridgeland, SC

Risk level
Class II
Reported by FDA
Sep 21, 2022
Recall ID
D-1524-2022
Check your lot numberHow we source this data

Summary

Carolina Infusion recalled Test Cyp/Dhea starting Aug 26, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1524-2022 on Sep 21, 2022. Reason: Lack of Assurance of Sterility. Status: Completed.

Why it was recalled

Lack of Assurance of Sterility

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the USA.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1524-2022
Classification
Class II
Status
Completed
Recall initiated
Aug 26, 2022
FDA report date
Sep 21, 2022
Quantity
348 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Carolina Infusion

Original FDA data

Every field from FDA enforcement report D-1524-2022, exactly as published.

Show all FDA fields
City
Ridgeland
State
SC
Status
Completed
Country
United States
Event ID
90798
Address
95 Bees Creek Rd
Code information
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
Postal code
29936-7540
Report date
Sep 21, 2022
Product type
Drugs
Recall number
D-1524-2022
Classification
Class II
Recalling firm
Carolina Infusion
Product quantity
348 vials
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the USA.
Recall initiation date
Aug 26, 2022
Initial firm notification
E-Mail
Center classification date
Sep 15, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1524-2022, published Sep 21, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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