The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0027-2020·Announced 2019-10-09

Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for 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.

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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable medications) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Colonia Care Pharmacy is recalling 5 mL vials of C-Papav/Phentol/PGE1 (30mg/1mg/30mcg/mL) prescription medication. The recall is being conducted because the company cannot guarantee the sterility of the product. The affected product is identified by Lot # 062419C with a beyond-use date of 08/08/19.

The recalled medication was distributed via patient-specific prescriptions in New Jersey. The source text does not specify the exact number of units recalled or the number of patients affected.

Patients who have received this medication should contact their healthcare provider or pharmacy for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/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 Medication
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 #: 062419C
  • 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 →

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