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.
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 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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