PlainRecalls
FDA Drug Moderate Class II Terminated

HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.

Reported: October 22, 2014 Initiated: October 1, 2014 #D-0016-2014

Product Description

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.

Details

Units Affected
197 vials
Distribution
Nationwide
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.. Recalled by Avella of Deer Valley, Inc.. Units affected: 197 vials.
Why was this product recalled?
Crystallization: Formation of crystals observed in product.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 22, 2014. Severity: Moderate. Recall number: D-0016-2014.