FDA Enforcement Report - Week of February 24, 2016--Abbott's Compounding Pharmacy, Inc.

Drugs	Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All Lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All Lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All Lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All Lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	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	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All Lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	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	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	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	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.
Drugs	papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705	All lots	Class II	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.	Abbott's Compounding Pharmacy, Inc.