FDA recall D-0709-2016

Product

papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 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.

Distribution

CA

Key facts

Status

Terminated

Initiation date

2016-01-15

Report date

2016-02-24

Termination date

2017-04-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berkeley, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0709-2016