CLASS II Drug recall · Reported 9 Oct 2019 · FDA Enforcement Report

C-papav/Phentol/PGE1 18MG/0.6MG/5.8MCG/ML vial recalled

Colonia Care Pharmacy is recalling C-papav/Phentol/PGE1 18MG/0.6MG/5.8MCG/ML vial, distributed in New Jersey. The recall was initiated on 24 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 072419C, BUD 09/07/19; 071519D, BUD 08/29/19

Quantity recalled2 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0021-2020
FDA event ID: 83427
Recalling firm: Colonia Care Pharmacy, Colonia, NJ
Classification: Class II
Status: Terminated
Recall initiated: 24 Jul 2019
FDA classified: 1 Oct 2019
Reported: 9 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

24 Jul 2019	Recall initiated by company
1 Oct 2019	Classified by FDA	+69 days
9 Oct 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Where it was distributed

Patient Specific Prescriptions in NJ

New Jersey

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Which lots are affected?

Lot #: 072419C, BUD 09/07/19; 071519D, BUD 08/29/19

Where was it sold?

Patient Specific Prescriptions in NJ

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

31 other products · FDA event 83427

This product is part of a recall event; the main page for the event is C-albumin 5% Ophth Solution droptainer recalled by Colonia Care Pharmacy.

Reported	Class	Recall	Company	Reason	Where
9 Oct 2019	CLASS II	C-albumin 5% Ophth Solution droptainer recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-methylcobalamin 25mg/ML Injection Pfs recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-verapamil 2.5MG/ML Inj Soln vial recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/Phentol/PGE1 30MG/2MG/20MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/Phentol/PGE1 18MG/0.6MG/5.88MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-urea 40% Bladder Instill vial recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/phentol/pge1 20mg/2mg/20mcg/ML recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-interferon ALFA2B 1MILU/ML Ophthal Solution droptainer recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/Phentol/PGE1 10MG/1MG/20MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-atropine Sulf Ophth 0.02% droptainer recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-tacrolimus 0.03% Ophthal Suspension droptainer recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-acetylcysteine Ophth 10% Soln recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-dexamethasone 24mg/ML Inj Solution recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-MB12 NAC 13MG/48MG/ML INJ SOLN in a syringe recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-cromolyn Sod 20 MG/ Inhalation Solution in 60 nebulizer vials recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/phentol/pge1 10mg/1mg/10mcg/ML recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-MB12/HB12 5MG/5MG/ML INJ SOLN in a syringe recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-calcium Glucnate 1% Injection Soln vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/Phentol/PGE1 30MG/1MG/20MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-hydroxyprogesterone Capro 250MG/ML Injection vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/Phentol/PGE1 30MG/1MG/50MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-hydroxocobalamin 5 MG/ML Injection Solution syringe recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-atropine Sulf Ophth 0.01% droptainer recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-hydroxocobalamin 25 MG/ML Injection Solution syringe recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/Phentol/PGE1 30MG/0.5MG/30MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-gentamicin 30MG/ML Inj Solution Sdv vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/Phentol/PGE1 18MG/0.6MG/11.8MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-phenol/Cottonseed Oil Inj 5% vial recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/Phentol/PGE1 30MG/1MG/30MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-papav/Phentol/PGE1 30MG/2MG/5MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019	CLASS II	C-edetate Disodium 1.5% Ophth Solution droptainer recalled	Colonia Care Pharmacy	Sterility	NJ

More recalls from Colonia Care Pharmacy

All 34

Reported	Class	Recall	Company	Reason	Where
9 Oct 2019Drug	CLASS II	C-edetate Disodium 1.5% Ophth Solution droptainer recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019Drug	CLASS II	C-papav/Phentol/PGE1 30MG/2MG/5MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019Drug	CLASS II	C-papav/Phentol/PGE1 30MG/1MG/30MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019Drug	CLASS II	C-phenol/Cottonseed Oil Inj 5% vial recalled by Colonia Care Pharmacy	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019Drug	CLASS II	C-papav/Phentol/PGE1 18MG/0.6MG/11.8MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ

Other C-papav recalls

All 12

Reported	Class	Recall	Company	Reason	Where
9 Oct 2019Drug	CLASS II	C-papav/Phentol/PGE1 30MG/2MG/5MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019Drug	CLASS II	C-papav/Phentol/PGE1 30MG/1MG/30MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019Drug	CLASS II	C-papav/Phentol/PGE1 18MG/0.6MG/11.8MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019Drug	CLASS II	C-papav/Phentol/PGE1 30MG/0.5MG/30MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ
9 Oct 2019Drug	CLASS II	C-papav/Phentol/PGE1 30MG/1MG/50MCG/ML vial recalled	Colonia Care Pharmacy	Sterility	NJ