The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0019-2020·Announced 2019-10-09

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

Colonia Care Pharmacy is recalling 6 vials of C-Papav/Phentol/PGE1 due to a lack of assurance of sterility. The affected 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable medications.

Plain-English summary

Colonia Care Pharmacy is recalling 6 vials of C-Papav/Phentol/PGE1 10MG/1MG/10MCG/ML. The product is packaged in 5 mL and 10 mL vials and is available by prescription only. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.

The affected product is identified by Lot # 071119E with a beyond-use date of 08/25/19. It was distributed through patient-specific prescriptions in New Jersey.

Patients who have received this medication should contact their healthcare provider or pharmacy for further instructions on how to proceed.

The recalled product

Product
C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Manufacturer
Colonia Care Pharmacy
Category
Drug — Injectable
Hazard
Affected units
6

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) 071119E
  • BUD 08/25/19

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

Same manufacturer · Colonia Care Pharmacy

See all →

Same hazard · sterility

See all →

Similar recalls