FDA Drug Recalls

Recalls / Class II

Class IID1092-2015

Product

ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

Affected lot / code info
All lots

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Advanced Physician Solutions, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
7225 Fulton Ave, N Hollywood, California 91605-4111

Distribution

Quantity
6 vials
Distribution pattern
Nationwide

Timeline

Recall initiated
2015-05-18
FDA classified
2015-05-28
Posted by FDA
2015-06-03
Terminated
2015-11-16
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D1092-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.