Colonia Care Pharmacy Recalls C-Hydroxocobalamin Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling 15 syringes of C-Hydroxocobalamin 25 mg/mL injection solution because the product's sterility 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are typically scored as Severe (4), particularly when involving sterility issues in injectable products which carry significant risk.
Plain-English summary
Colonia Care Pharmacy is recalling 15 syringes of C-Hydroxocobalamin 25 mg/mL injection solution. The product is a prescription-only medication distributed in 1 mL syringes. The specific lot number is 070919E, with a beyond-use date of August 23, 2019.
The recall was initiated because the product's sterility cannot be guaranteed. This lack of assurance of sterility poses a potential risk to patients who use the injection.
The affected product was distributed via 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-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
- Manufacturer
- Colonia Care Pharmacy
- Category
- Drug — Injection
- Affected units
- 15
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 #: 070919E
- BUD 08/23/19
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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