Injectable hydroxocobalamin vials recalled due to sterility concerns
Pharmacy Innovations is recalling hydroxocobalamin-PF injectable vials (1mg/ml) distributed nationwide because FDA inspection found insanitary conditions at the manufacturing facility that could compromise product sterility.
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: FDA Class II recall for lack of sterility assurance at the manufacturing facility. No illnesses or injuries have been reported, but non-sterile injectable medications pose a significant risk of infection, meeting the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pharmacy Innovations is recalling hydroxocobalamin-PF injectable solution (1mg/ml in 1ml vials) that was distributed nationwide. The product is a prescription-only injectable medication.
The recall was issued after an FDA inspection discovered insanitary conditions at the manufacturing facility. These conditions resulted in a lack of assurance that the product maintained sterility during manufacturing, which is critical for injectable medications.
Healthcare providers and patients who have received this medication should contact their healthcare provider to discuss any concerns. Facilities or individuals with affected vials should discontinue use and contact their pharmacy or healthcare provider for guidance on proper product disposal and alternative treatment options.
The recalled product
- Product
- HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable
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)
- t20221116@36 t20221117@11 t20221111@61
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.
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