Injectable Hydroxocobalamin Recalled Due to Sterility Assurance Failure
Pharmacy Innovations is recalling Hydroxocobalamin 25MG/ML injectable vials nationwide due to insanitary facility conditions identified during FDA inspection that compromise sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall due to insanitary facility conditions compromising sterility assurance. No illnesses or injuries are reported. This represents a risk-of-harm product where the potential for contamination exists but has not resulted in confirmed adverse health events.
Plain-English summary
Pharmacy Innovations is recalling all lots of Hydroxocobalamin 25MG/ML injectable vials (2ML vials) distributed nationwide. This is a prescription-only injectable medication.
The recall was initiated following an FDA inspection that identified insanitary conditions at the manufacturing facility in Erie, Pennsylvania. These conditions compromised the assurance of product sterility, a critical requirement for injectable medications.
The affected product was distributed nationwide. Healthcare providers and patients may have received doses of this medication.
Patients and healthcare providers who have this medication should discontinue use and contact their pharmacy or Pharmacy Innovations for guidance on returns and appropriate alternatives.
The recalled product
- Product
- Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Hazard
- sterility-failure
- contamination-risk
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 (1)
- t20221025@33
Distribution
Distributed nationwide across the United States.
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