D-1088-2019 Class II Terminated

Recall Details

ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Dispensed in Oregon

Lots: 17012019@13, 30012019@36, 01022019@4, 14022019@1, 19022019@18, 19022019@60, distributed between 09-01-2018 to 02-20-2019.

D-1100-2019 Class II — PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding P (February 21, 2019)
D-1095-2019 Class II — PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professi (February 21, 2019)
D-1107-2019 Class II — PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional (February 21, 2019)
D-1101-2019 Class II — PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional (February 21, 2019)
D-1105-2019 Class II — PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional (February 21, 2019)
D-1092-2019 Class II — PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injecti (February 21, 2019)
D-1098-2019 Class II — PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compou (February 21, 2019)
D-1099-2019 Class II — PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding (February 21, 2019)
D-1104-2019 Class II — PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professi (February 21, 2019)
D-1087-2019 Class II — DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professio (February 21, 2019)