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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
Part of a larger recall action
This product is one of 59 recalled by Pharmacy Innovations under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 59 products in this recall →Related recalls
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