Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance issues for injectable products.
Plain-English summary
Colonia Care Pharmacy is recalling C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vials, prescription only. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.
The affected product is identified by Lot # 072419B with a Beyond Use Date of 09/07/19. This product was distributed via patient-specific prescriptions in New Jersey.
Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 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 #: 072419B
- BUD 09/07/19
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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