PlainRecalls
FDA Drug Moderate Class II Terminated

hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

Reported: February 24, 2016 Initiated: January 15, 2016 #D-0683-2016

Product Description

hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

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.

Details

Units Affected
20 ml
Distribution
CA
Location
Berkeley, CA

Frequently Asked Questions

What product was recalled?
hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705. Recalled by Abbott's Compounding Pharmacy, Inc.. Units affected: 20 ml.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 24, 2016. Severity: Moderate. Recall number: D-0683-2016.