Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns
Colonia Care Pharmacy is recalling 7 vials of C-Papav/Phentol/PGE1 due to a lack of assurance of sterility. The product was distributed via 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 classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a parenteral product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Colonia Care Pharmacy is recalling 7 vials of C-Papav/Phentol/PGE1 20mg/2mg/20mcg/mL. The product is packaged in 5 mL and 10 mL vials and is available by prescription only. The specific lot number is 070519A, with a beyond-use date of August 19, 2019.
The recall was initiated because the sterility of the product cannot be guaranteed. This lack of assurance of sterility poses a potential risk to patients using the medication.
The affected product was distributed through patient-specific prescriptions in New Jersey. Patients who have received this medication should contact their healthcare provider or pharmacist for further instructions on how to proceed.
The recalled product
- Product
- C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Pharmacy Compounded
- Hazard
- Affected units
- 7
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 #: a) and b) 070519A
- BUD 08/19/19
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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