Injectable Magnesium Chloride Recalled Due to Facility Contamination Concerns
Pharmacy Innovations is recalling magnesium chloride hexahydrate injectable (5 mL vials) distributed nationwide due to insanitary facility conditions that compromise 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: FDA Class II recall of a sterile injectable product. FDA inspection revealed insanitary facility conditions that compromise sterility assurance. No illnesses or injuries have been reported, but this qualifies as a risk-of-harm product where infection could result if contaminated product reaches patients.
Plain-English summary
Pharmacy Innovations is recalling magnesium chloride hexahydrate injectable solution (200 mg/mL, 5 mL vials) distributed nationwide. The product is a prescription injectable medication.
FDA inspection of the manufacturing facility identified insanitary conditions. These conditions create a lack of assurance regarding the sterility of the product. Sterile injectables contaminated with bacteria or other microorganisms can cause serious infections in patients, including sepsis and other life-threatening complications.
Healthcare providers and patients who have or may have received this product should consult their healthcare provider about whether they have been affected. Patients should not discontinue use of their prescribed medication without medical guidance. Healthcare facilities should verify whether affected units (code t20221011@36) were received and follow appropriate protocols for secure disposal or return to the manufacturer.
The recalled product
- Product
- MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable / Intravenous
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)
- t20221011@36
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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