Lidocaine-Epinephrine Injectable Vials Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000 injection vials due to lack of sterility assurance. The recall affects 310 vials distributed nationwide.
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 a sterile injectable pharmaceutical with no reported illnesses or injuries. The lack of sterility assurance in multi-dose injection vials represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000/mL Multi-Dose 30 mL vials (NDC 73198-0099-30) due to lack of assurance of sterility. The recall includes 310 vials with lot K41023 and beyond-use date of 5/23/2022, distributed nationwide across the USA, Puerto Rico, and US Virgin Islands.
This injectable medication is used for local anesthesia with vasoconstriction in medical and dental procedures. A failure to ensure sterility in multi-dose vials poses a potential contamination risk to patients receiving injections from affected vials.
Healthcare providers and patients who possess vials from this lot should cease use immediately and contact Olympia Compounding Pharmacy or their healthcare provider for guidance on safe disposal and alternative products. No illnesses or injuries have been reported as of the recall announcement.
The recalled product
- Product
- Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0099-30
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- sterility-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 (1)
- Lot: K41023 BUD: 5/23/2022
Distribution
Distributed nationwide across the United States.
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