Colonia Care Pharmacy Recalls C-Phenol Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling C-Phenol/Cottonseed Oil Injection 5% vials because the sterility of the product cannot be guaranteed.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are rated as Severe (4).
Plain-English summary
Colonia Care Pharmacy is recalling C-Phenol/Cottonseed Oil Injection 5%, 5 mL vials, prescription only. The recall is due to a lack of assurance of sterility, meaning the sterility of the product cannot be guaranteed.
The affected product is identified by Lot # 070319F with a Beyond Use Date of 08/17/19. The distribution pattern is limited to patient-specific prescriptions in New Jersey.
Patients who have received this medication should contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 070319F
- BUD 08/17/19
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 32 recalled by Colonia Care Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 32 products in this recall →Related recalls
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