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.
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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe. While specific injury reports are not detailed in the text, the agency classification of Class II for a sterile injectable product due to lack of sterility assurance aligns with the Severe criteria for significant risk.
Plain-English summary
Colonia Care Pharmacy is recalling 5 mL vials of C-Papav/Phentol/PGE1 (30mg/1mg/50mcg/mL). The recall is being conducted because the company cannot guarantee the sterility of the product.
The affected product is identified by Lot # 062419B with a beyond-use date of 08/08/19. These prescription-only vials were distributed to patients in New Jersey via specific prescriptions.
Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on what to do next.
The recalled product
- Product
- C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/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
- 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 #: 062419B
- BUD 08/08/19
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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