Methylcobalamin Injectable Recall Due to Facility Sterility Assurance Failure
Pharmacy Innovations is recalling injectable methylcobalamin products in multiple strengths due to lack of sterility assurance. FDA inspection revealed insanitary facility conditions that compromise product safety.
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: This is an FDA Class II recall of injectable pharmaceutical products with a manufacturing defect (insanitary facility conditions) that compromises sterility assurance. Injectable products must be sterile to be safe; this recall represents a risk-of-harm situation. No illnesses or injuries are reported in the source.
Plain-English summary
Pharmacy Innovations, located in Erie, Pennsylvania, is recalling multiple injectable methylcobalamin products that were distributed nationwide. The recalled products include methylcobalamin 3 mg/ml, 5 mg/ml (in 0.2 ml and 1 ml vials), 12.5 mg/ml, and 25 mg/ml formulations. These are prescription-only injectable medications.
The recall was initiated due to lack of assurance of sterility. During an FDA inspection of the manufacturing facility, insanitary conditions were identified. Because these are injectable products that must be sterile to ensure patient safety, the insanitary facility conditions create a risk that products may be contaminated or lose their sterility.
Patients and healthcare providers who have these products in use or storage should contact Pharmacy Innovations or consult their healthcare provider regarding this recall. Healthcare professionals should determine the appropriate action for patients who may have received these recalled products.
The recalled product
- Product
- METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 3MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (0.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 12.5MG/ML (1ML VIAL) IN
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable / Vitamin B12
- Hazard
- sterility-failure
- contamination-risk
Distribution
Distributed nationwide across the United States.
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