Colonia Care Pharmacy

FDA Regulatory Profile

Summary

Total Recalls
34
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0006-2020Class IIC-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave.July 24, 2019
D-0028-2020Class IIC-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., SJuly 24, 2019
D-0023-2020Class IIC-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman AvJuly 24, 2019
D-0026-2020Class IIC-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., SJuly 24, 2019
D-0005-2020Class IIC-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave.July 24, 2019
D-0014-2020Class IIC-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 InmanJuly 24, 2019
D-0011-2020Class IIC-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., SuJuly 24, 2019
D-0022-2020Class IIC-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman AveJuly 24, 2019
D-0004-2020Class IIC-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman AveJuly 24, 2019
D-0008-2020Class IIC-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care PJuly 24, 2019
D-0003-2020Class IIC-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, ColonJuly 24, 2019
D-0010-2020Class IIC-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515July 24, 2019
D-0025-2020Class IIC-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave.,July 24, 2019
D-0034-2020Class IIC-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, July 24, 2019
D-0024-2020Class IIC-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, Colonia CareJuly 24, 2019
D-0020-2020Class IIC-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., SJuly 24, 2019
D-0009-2020Class IIC-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care PharJuly 24, 2019
D-0027-2020Class IIC-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., SJuly 24, 2019
D-0033-2020Class IIC-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, ColJuly 24, 2019
D-0030-2020Class IIC-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., SJuly 24, 2019