Pharmacy Innovations Progesterone Injectable Vial Recalled for Sterility Concerns
Pharmacy Innovations is recalling PROGESTERONE-GS OIL 100MG/ML injectable vials distributed nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
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: This is an FDA Class II recall of an injectable pharmaceutical with no reported illnesses or injuries. The hazard—lack of sterility assurance due to insanitary facility conditions—represents a risk of serious patient harm, but no actual injury has been reported. Per the rubric, recalls with theoretical hazards and no reported injuries score at most 3 (High).
Plain-English summary
Pharmacy Innovations is recalling PROGESTERONE-GS OIL 100MG/ML (2ML VIAL) INJECTABLE vials that were distributed nationwide. The recall was initiated because FDA inspection revealed insanitary conditions at the Pharmacy Innovations facility in Erie, Pennsylvania, resulting in a lack of assurance of sterility for the product.
Injectable drugs must be manufactured under strict sterility standards to prevent contamination and potential patient harm. The insanitary conditions found during the FDA inspection raised concerns about whether this product meets those standards.
Patients who have received this medication or healthcare facilities with this product should consult with their pharmacist or healthcare provider. Further guidance regarding this recall may be available from the FDA or Pharmacy Innovations.
The recalled product
- Product
- PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable / Hormone
- Hazard
- sterility-issue
- 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)
- t20221116@36
Distribution
Distributed nationwide across the United States.
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