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Colonia Care Pharmacy

FDA Regulatory Profile

Colonia Care Pharmacy has 34 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0012-2020 · Class II · Jul 24, 2019
Latest inspection
Jul 26, 2021 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls34Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0012-2020Class IIC-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515…Jul 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…Jul 24, 2019
D-0005-2020Class IIC-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman…Jul 24, 2019
D-0029-2020Class IIC-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave…Jul 24, 2019
D-0004-2020Class IIC-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman…Jul 24, 2019
D-0026-2020Class IIC-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave…Jul 24, 2019
D-0014-2020Class IIC-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman…Jul 24, 2019
D-0011-2020Class IIC-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave…Jul 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…Jul 24, 2019
D-0008-2020Class IIC-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care…Jul 24, 2019
D-0007-2020Class IIC-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave…Jul 24, 2019
D-0010-2020Class IIC-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515…Jul 24, 2019
D-0032-2020Class IIC-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515…Jul 24, 2019
D-0003-2020Class IIC-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only…Jul 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…Jul 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 Care…Jul 24, 2019
D-0006-2020Class IIC-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman…Jul 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…Jul 24, 2019
D-0009-2020Class IIC-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care…Jul 24, 2019
D-0027-2020Class IIC-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave…Jul 24, 2019

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 26, 2021Colonia, NJDrugsOfficial Action Indicated (OAI)3012223534
Apr 22, 2019Colonia, NJDrugsOfficial Action Indicated (OAI)3012223534
Apr 15, 2016Colonia, NJDrugsOfficial Action Indicated (OAI)3012223534

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3012223534Colonia, NJ3Jul 26, 2021

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.