Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific lots of C-Papav/Phentol/PGE1 vials 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While specific injury reports are not detailed in the text, the agency classification of Class II for a sterility issue in a drug product aligns with the Severe criteria for significant risk.
Plain-English summary
Colonia Care Pharmacy is recalling 2 vials of C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.
The affected product includes Lot # 072419C with a best use date of 09/07/19 and Lot # 071519D with a best use date of 08/29/19. These products were distributed as patient-specific prescriptions in New Jersey.
Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions on how to proceed.
The recalled product
- Product
- 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
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2
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 (4)
- Lot #: 072419C
- BUD 09/07/19
- 071519D
- BUD 08/29/19
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.
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