FDA Recalls Injectable Glycerin 72% Due to Sterility Assurance Failure
Pharmacy Innovations is recalling Injectable Glycerin 72% (15mL vials) nationwide due to lack of sterility assurance discovered during FDA facility inspection.
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 for injectable pharmaceutical product. The hazard is lack of assurance of sterility due to insanitary facility conditions. No illnesses, injuries, or hospitalizations are reported in the source. Per the rubric, theoretical risk-of-harm hazards without reported injury score at most 3 (High).
Plain-English summary
Pharmacy Innovations is recalling Injectable Glycerin 72% (W/V) in 15mL vials (product code t20221117@11) nationwide due to lack of assurance of sterility.
FDA inspection of the Pharmacy Innovations facility in Erie, Pennsylvania revealed insanitary conditions. These conditions raised concerns about whether affected units meet required sterility standards for injectable pharmaceuticals.
The recall affects all units with product code t20221117@11 distributed nationwide in the United States.
The recalled product
- Product
- GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable Pharmaceutical
- Hazard
- sterility-failure
- contamination
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)
- t20221117@11
Distribution
Distributed nationwide across the United States.
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