The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0024-2020·Announced 2019-10-09

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.

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 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 →

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