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.
D-0016-2014
Product summary
- Event
- Event 69405
- Status
- Terminated
- Classification
- Class II
- Quantity
- 197 vials
- Official record key
drug-enforcement:D-0016-2014
Official wording
Reason: Crystallization: Formation of crystals observed in product.
Code information: Lot# 12-20140207@109; Exp. 12/14 Lot# 12-20142107@82; Exp. 01/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Crystallization: Formation of crystals observed in product.