Colonia Care Pharmacy Recalls C-Hydroxocobalamin Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling C-Hydroxocobalamin 5 mg/mL injection syringes because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
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, and the hazard involves a lack of assurance of sterility in an injectable drug, which carries a risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Colonia Care Pharmacy is recalling C-Hydroxocobalamin 5 mg/mL injection solution, 1 mL syringes, prescription only. The recall is due to a lack of assurance of sterility, meaning the sterility of the product cannot be guaranteed.
The affected product is identified by Lot # 062619E with a beyond-use date of 08/10/19. The quantity involved is 30 syringes. Distribution was limited to patient-specific prescriptions in New Jersey.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- C-HYDROXOCOBALAMIN 5 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 — Injectable Solution
- Affected units
- 30
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 #: 062619E
- BUD 08/10/19
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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