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Colonia Care Pharmacy

Complete recall history across all FDA and CPSC categories — 34 total recalls

Colonia Care Pharmacy appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (34)

FDA drug safety enforcement actions by Colonia Care Pharmacy

Date Product Reason Class
Jul 24, 2019 C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Col... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 51... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Ph... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Coloni... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia C... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia C... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vial... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colon... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colon... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx onl... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 I... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 51... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, an... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 24, 2019 C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II
Jul 28, 2016 C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy,... Lack of Assurance of Sterility; sterility concerns with all injectable drug p... Class II
Jul 28, 2016 C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pha... Lack of Assurance of Sterility; sterility concerns with all injectable drug p... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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