hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

Recall Number: D-0682-2016

Firm: Abbott's Compounding Pharmacy, Inc.

Classification: Class II

Status: Terminated

Report Date: 20160224

Initiation Date: 20160115

Termination Date: 20170406

Reason for Recall

Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

Product Description

hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705