The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0022-2020·Announced 2019-10-09

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 sterility of the product 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 are assigned a score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance in injectable products.

Plain-English summary

Colonia Care Pharmacy is recalling 5 mL vials of C-Papav/Phentol/PGE1 (18mg/0.6mg/5.88mcg/mL). The recall is being conducted because the company cannot guarantee the sterility of the product. The affected product is prescription-only and was distributed via patient-specific prescriptions in New Jersey.

The specific lot number for the recalled product is 071519E, with a beyond-use date of 08/29/19. The agency has classified this recall as Class II. No specific illnesses or injuries are reported in the source text.

Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on what to do with the recalled product.

The recalled product

Product
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 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
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 #: 071519E
  • 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.

See all 32 products in this recall →

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