The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0014-2020·Announced 2019-10-09

Colonia Care Pharmacy Recalls C-Hydroxyprogesterone Caproate Injections for Sterility Concerns

Colonia Care Pharmacy is recalling 18 vials of C-Hydroxyprogesterone Caproate 250mg/mL injections because the sterility of the product cannot be guaranteed.

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, an FDA Class II recall involving a significant hazard such as a lack of sterility assurance in an injectable product corresponds to a Severe (4) rating.

Plain-English summary

Colonia Care Pharmacy is recalling 18 vials of C-Hydroxyprogesterone Caproate 250mg/mL injections. The recall is due to a lack of assurance of sterility, meaning the sterility of the product cannot be guaranteed.

The affected product is a prescription-only medication distributed via patient-specific prescriptions in New Jersey. The recall includes three specific lots: 041119A (Best Use Date 10/08/19), 051019J (Best Use Date 11/6/19), and 070519C (Best Use Date 01/01/20).

Patients who have received this medication should contact their healthcare provider for guidance on next steps.

The recalled product

Product
C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Manufacturer
Colonia Care Pharmacy
Category
Drug — Injectable Sterile Product
Hazard
Affected units
18

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 (6)

  • Lot #: 041119A
  • BUD 10/08/19
  • 051019J
  • BUD 11/6/19
  • 070519C
  • BUD 01/01/20

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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