Agency classClass IIOur severity:High FDA (Drugs)·D-0222-2023·Announced 2023-02-01

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.

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 3/5 (High).

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)…
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable / Vitamin B12
Hazard: sterility-failure
contamination-risk

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by Pharmacy Innovations 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 59 products in this recall →

Same manufacturer · Pharmacy Innovations

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