Clindamycin/EDTA Calcium Irrigation Solution Recalled for Lack of Sterility Assurance
Pharmacy Innovations is recalling Clindamycin/EDTA Calcium irrigation solution (30ML syringe) distributed nationwide due to lack of assurance of sterility caused by insanitary conditions found during FDA 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 lack of sterility assurance due to insanitary facility conditions. This is a risk-of-harm pharmaceutical product where no illnesses have yet been reported, warranting a High severity rating per the rubric.
Plain-English summary
Pharmacy Innovations is recalling Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML irrigation solution supplied in 30ML syringes. This is a prescription-only pharmaceutical product.
The recall was initiated following FDA inspection of the manufacturing facility, which revealed insanitary conditions that created a lack of assurance of sterility.
The product was distributed nationwide in the United States. The affected batch is identified by code t20221109@41.
The recalled product
- Product
- Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Hazard
- contamination
- lack-of-sterility
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)
- t20221109@41
Distribution
Distributed nationwide across the United States.
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