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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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