Colonia Care Pharmacy Recalls Dexamethasone Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling 37 vials of C-Dexamethasone 24mg/mL injection solution 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, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of infection or serious injury.
Plain-English summary
Colonia Care Pharmacy is recalling 37 vials of C-Dexamethasone 24mg/mL injection solution. The product is packaged in 1 mL single-dose vials and is available by prescription only. The recall was initiated because the company cannot guarantee the sterility of the product.
The affected lots are 070319G with a beyond-use date of 08/17/19, and 071219P with a beyond-use date of 08/26/19. These products were distributed via patient-specific prescriptions in New Jersey.
Patients who have received this medication should contact their healthcare provider or pharmacist for further instructions on how to proceed.
The recalled product
- Product
- C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Injectable Solution
- Affected units
- 37
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 (4)
- Lot #: 070319G
- BUD 08/17/19
- 071219P
- BUD 08/26/19
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.
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