RecallRadar

FDA Drug recall D-0016-2014

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

On 2014-10-22 the FDA classified a Class II recall of HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix,… by Avella, citing crystallization: Formation of crystals observed in product.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0016-2014
ClassificationClass II
Statusterminated
Initiated2014-10-01
Published2014-10-22
Last updated2026-09-13 11:51 UTC
CompanyAvella
DistributionUS

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

Crystallization: Formation of crystals observed in product.

Identifiers

code_infoLot# 12-20140207@109; Exp. 12/14 Lot# 12-20142107@82; Exp. 01/15

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0016-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.