Edetate Calcium Disodium Injectable Recalled for Sterility Assurance Concerns
Pharmacy Innovations is recalling Edetate Calcium Disodium 400MG/ML injectable vials nationwide due to insanitary manufacturing conditions that compromise sterility assurance.
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 with no reported illnesses or injuries. The hazard (lack of sterility assurance in an injectable drug) presents significant risk of harm through potential contamination, meeting the criterion of "risk-of-harm products where injury has not yet been reported."
Plain-English summary
Pharmacy Innovations is recalling Edetate Calcium Disodium 400MG/ML (30ML vial) injectable vials that were distributed nationwide. The recall is due to lack of assurance of sterility. FDA inspection revealed insanitary conditions at the manufacturing facility located at 2936 W 17th St., Erie, PA.
When manufacturing conditions are insanitary, there is risk that an injectable product may become contaminated. The FDA issued this recall because the manufacturing conditions do not provide assurance that the product is free from contamination.
Patients who have received this medication should consult their healthcare provider or pharmacist. The affected product can be identified by code t20221013@15. Do not use affected units.
The recalled product
- Product
- Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- contamination-risk
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)
- t20221013@15
Distribution
Distributed nationwide across the United States.
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