FDA-Drug2016-02-24Class II

papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

Abbott's Compounding Pharmacy, Inc.
Hazard

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.

Sold states
CA
Affected count
5 ml
Manufactured in
2320 Woolsey St, Berkeley, CA, United States
Products
papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0698-2016

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