Colonia Care Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Gentamicin injection 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable products.
Plain-English summary
Colonia Care Pharmacy is recalling C-Gentamicin 30mg/mL Injection Solution, Single Dose Vial (3 mL), prescription only. The recall involves Lot # 070319J with a beyond-use date of 08/17/19.
The recall was initiated due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed. This product was distributed to patient-specific prescriptions in New Jersey.
Patients who received this medication should contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Injectable
- 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 #: 070319J
- BUD 08/17/19
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
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