Colonia Care Pharmacy Recalls Sterility-Compromised C-Papav/Phentol/PGE1 Vials
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in a parenteral product.
Plain-English summary
Colonia Care Pharmacy is recalling 5 mL vials of C-Papav/Phentol/PGE1 30mg/2mg/20mcg/mL. The recall is being conducted because the company cannot guarantee the sterility of the product.
The affected product is identified by Lot # 070319A with a beyond-use date of 08/17/19. This prescription-only medication was distributed to patients in New Jersey via patient-specific prescriptions.
Patients who have received this medication should contact their healthcare provider or pharmacist for instructions on how to proceed.
The recalled product
- Product
- C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- 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 #: 070319A
- 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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