Injectable Vitamin D3 Recalled Over Sterility Concerns at Manufacturing Facility
Pharmacy Innovations recalls Cholecalciferol (Vitamin D3) 100,000U/ML Injectable nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility assurance.
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: FDA Class II recall with no reported illnesses or injuries. The hazard—insanitary facility conditions affecting a sterile injectable product—represents a contamination risk without confirmed harm, placing this at High severity.
Plain-English summary
Pharmacy Innovations, located in Erie, Pennsylvania, has recalled Cholecalciferol (Vitamin D3) 100,000U/ML Injectable nationwide. The recall was initiated after FDA inspection revealed insanitary conditions at the manufacturing facility.
The product is an injectable vitamin D3 supplement available only by prescription. Because it is an injectable preparation, any compromise to sterility assurance poses a potential health risk. The insanitary conditions found during FDA inspection raise concerns that the manufacturing environment may not meet required standards for producing sterile injectable pharmaceuticals.
Patients currently using this product should consult their healthcare provider immediately. Do not stop taking your medication without medical guidance. Your healthcare provider can advise whether this product should be discontinued or replaced with an alternative source of vitamin D supplementation.
Healthcare providers and pharmacies should quarantine all affected inventory and return it to the manufacturer according to the recall instructions.
The recalled product
- Product
- Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Hazard
- sterility-assurance
- insanitary-conditions
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)
- t20221130@14
Distribution
Distributed nationwide across the United States.
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