FDA recall D-0016-2014
Avella of Deer Valley, Inc. · Class II · drug
Product
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
Reason for recall
Crystallization: Formation of crystals observed in product.
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2014-10-01
- Report date
- 2014-10-22
- Termination date
- 2015-02-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Phoenix, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0016-2014