Pharmacy Innovations Methylcobalamin Injectable Solutions Recalled for Sterility Concerns
Pharmacy Innovations is recalling Methylcobalamin injectable solutions (1MG/ML, 3MG/ML, 5MG/ML vials) distributed nationwide. FDA inspection revealed insanitary conditions at the facility affecting product sterility assurance.
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 an injectable medication. Although no illnesses or injuries have been reported, the hazard of compromised sterility in an injectable product qualifies as a risk-of-harm product per the rubric, resulting in a Score 3.
Plain-English summary
Pharmacy Innovations is recalling Methylcobalamin injectable solutions available in 1MG/ML, 3MG/ML, and 5MG/ML concentrations in 1-milliliter vials. The recall affects products distributed nationwide.
The recall was initiated due to lack of assurance of product sterility. FDA inspection of the Pharmacy Innovations manufacturing facility in Erie, Pennsylvania revealed insanitary conditions that compromise sterility assurance.
Methylcobalamin is an injectable form of vitamin B12 prescribed for medical use. Patients who may have received injections from affected lot codes (t20221021@36, t20221025@32, t20221025@33) should contact their healthcare provider. Recalled product should not be used.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 5MG/ML (1ML vial) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable / Vitamin B12
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)
- t20221021@36 t20221025@32 t20221025@33
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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