CLASS II Drug recall · Reported 9 Oct 2019 · FDA Enforcement Report
C-phenol/Cottonseed Oil Inj 5% vial recalled by Colonia Care Pharmacy
Colonia Care Pharmacy is recalling C-phenol/Cottonseed Oil Inj 5% 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
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-0031-2020
- 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-PHENOL/COTTONSEED OIL INJ 5%, 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
Questions about this recall
Is C-phenol/Cottonseed Oil Inj 5% vial recalled?
Yes. Colonia Care Pharmacy recalled C-phenol/Cottonseed Oil Inj 5% vial on 24 Jul 2019. The recall is Class II and its status is Terminated. Recall number D-0031-2020.
Why was it recalled?
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Which lots are affected?
Lot #: 070319F, BUD 08/17/19
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Colonia Care Pharmacy
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | C-edetate Disodium 5% Ophth Solution droptainer recalled | Colonia Care Pharmacy | Sterility | NJ |
| Drug | CLASS II | C-papav/Phentol/PGE1 18MG/0.6MG/5.8MCG/ML vial recalled | Colonia Care Pharmacy | Sterility | NJ |
| Drug | CLASS II | C-papav/Phentol/PGE1 30MG/2MG/5MCG/ML vial recalled | Colonia Care Pharmacy | Sterility | NJ |
| Drug | CLASS II | C-papav/Phentol/PGE1 30MG/1MG/30MCG/ML vial recalled | Colonia Care Pharmacy | Sterility | NJ |
| Drug | CLASS II | C-papav/Phentol/PGE1 18MG/0.6MG/11.8MCG/ML vial recalled | Colonia Care Pharmacy | Sterility | NJ |