FDA Drug Recalls

Recalls / Class II

Class IID-1260-2019

Product

Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

Affected lot / code info
Lot #: 03112019@10, Exp 6/19/19

Why it was recalled

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Recalling firm

Firm
Customceutical Compounding
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
4611 E Shea Blvd Bldg 3 Ste 180, N/A, Phoenix, Arizona 85028-4258

Distribution

Quantity
5 vials
Distribution pattern
U.S.A. Nationwide

Timeline

Recall initiated
2019-04-08
FDA classified
2019-04-30
Posted by FDA
2019-05-08
Terminated
2023-05-19
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1260-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.