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Class II: temporary or reversible health riskTerminated

University Compounding Pharmacy Testosterone Cypionate Recall

Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compound…

University Compounding Pharmacy · San Diego, CA

Risk level
Class II
Reported by FDA
Sep 18, 2013
Recall ID
D-1020-2013
Check your lot numberHow we source this data

Summary

University Compounding Pharmacy recalled Testosterone Cypionate starting Sep 6, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1020-2013 on Sep 18, 2013. Reason: Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.

Product description

Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.

Lot numbers, UPCs & expiration codes

Lot 511017, Exp 11/30/2013

Where it was sold

Nationwide

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-1020-2013
Classification
Class II
Status
Terminated
Recall initiated
Sep 6, 2013
FDA report date
Sep 18, 2013
Quantity
178.2 mL
Recall type
Voluntary: Firm initiated
Recalling firm
University Compounding Pharmacy

Original FDA data

Every field from FDA enforcement report D-1020-2013, exactly as published.

Show all FDA fields
City
San Diego
State
CA
Status
Terminated
Country
United States
Event ID
66206
Address
1875 3rd Avenue
Code information
Lot 511017, Exp 11/30/2013
Postal code
92101
Report date
Sep 18, 2013
Product type
Drugs
Recall number
D-1020-2013
Classification
Class II
Recalling firm
University Compounding Pharmacy
Product quantity
178.2 mL
Termination date
Jan 21, 2014
Reason for recall
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Distribution pattern
Nationwide
Recall initiation date
Sep 6, 2013
Initial firm notification
Press Release
Center classification date
Sep 12, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1020-2013, published Sep 18, 2013. 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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