FDA-Drug2016-02-24Class II

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

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
10 ml
Manufactured in
2320 Woolsey St, Berkeley, CA, United States
Products
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

Official notice

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

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