Pharmacy Innovations Recalls Heparin Irrigation Solution Due to Sterility Concerns
Pharmacy Innovations is recalling a heparin-lidocaine irrigation solution 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: FDA Class II drug recall with no reported illnesses or injuries. The hazard is lack of sterility assurance in a sterile irrigation product due to insanitary manufacturing conditions, which presents a theoretical contamination risk.
Plain-English summary
Pharmacy Innovations, located in Erie, Pennsylvania, is recalling HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML irrigation solution in 20-milliliter syringes nationwide. The recall was initiated due to lack of assurance of sterility.
During a U.S. Food and Drug Administration (FDA) inspection of the manufacturing facility, insanitary conditions were discovered that compromise the sterile nature of the product. This product is a prescription-only irrigation solution used in medical settings.
Patients or healthcare providers who have this product in their possession should immediately stop use. If this product has already been used, patients should consult their healthcare provider regarding any potential health concerns. The affected product codes are t20221011@36 and t20221108@24.
The recalled product
- Product
- HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Irrigation Solution
- Hazard
- contamination
- sterile-product-failure
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 (2)
- t20221011@36
- t20221108@24
Distribution
Distributed nationwide across the United States.
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