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Class II: temporary or reversible health riskTerminated

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy Testosterone Cypionate In Sesame Oil 200mg/ml Recall

Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE CO…

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy · Murrieta, CA

Risk level
Class II
Reported by FDA
Apr 15, 2020
Recall ID
D-1098-2020
Check your lot numberHow we source this data

Summary

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy recalled Testosterone Cypionate In Sesame Oil 200mg/ml starting Mar 26, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1098-2020 on Apr 15, 2020. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

Lot numbers, UPCs & expiration codes

Lot #: 11152019@41,Expires after 04-07-2020; Lot # 12042019@12, Expires after 04-26-2020; Lot # 12172019@9, Expires after 05-09-2020; Lot # 01032020@49, Expires after 05-26-2020; Lot # 01162020@55, Expires after 06-08-2020

Where it was sold

Patient Distribution list includes addresses in the following states: CA, ME, TX

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-1098-2020
Classification
Class II
Status
Terminated
Recall initiated
Mar 26, 2020
FDA report date
Apr 15, 2020
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Original FDA data

Every field from FDA enforcement report D-1098-2020, exactly as published.

Show all FDA fields
City
Murrieta
State
CA
Status
Terminated
Country
United States
Event ID
85351
Address
41538 Eastman Dr Ste A
Code information
Lot #: 11152019@41,Expires after 04-07-2020; Lot # 12042019@12, Expires after 04-26-2020; Lot # 12172019@9, Expires after 05-09-2020; Lot # 01032020@49, Expires after 05-26-2020; Lot # 01162020@55, Expires after 06-08-2020
Postal code
92562-8007
Report date
Apr 15, 2020
Product type
Drugs
Recall number
D-1098-2020
Classification
Class II
Recalling firm
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Termination date
Jan 29, 2024
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Distribution pattern
Patient Distribution list includes addresses in the following states: CA, ME, TX
Recall initiation date
Mar 26, 2020
Initial firm notification
Letter
Center classification date
Apr 6, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1098-2020, published Apr 15, 2020. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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