Lidocaine 2% injectable solution recalled for lack of sterility assurance
Olympia Pharmaceuticals recalled 1195 vials of Lidocaine 2% due to lack of assurance of sterility. The vials were distributed nationwide and should not be used.
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 of a sterile pharmaceutical product. While no illnesses or injuries are reported, this is a risk-of-harm product (injectable medication) where sterility failure could result in serious infection. Per the rubric, 'risk-of-harm products where injury has not yet been reported' warrant a score of 3.
Plain-English summary
Olympia Compounding Pharmacy, also known as Olympia Pharmacy, is recalling 1195 vials of Lidocaine 2% (20 mg/mL) multi-dose vials (NDC 73198-0097-30). Two lot codes are affected: Lot L246022 (beyond-use date 6/22/2022) and Lot B24208-22 (beyond-use date 8/8/2022).
The recall was initiated due to lack of assurance of sterility. Sterility is essential for injectable medications, particularly multi-dose vials used in healthcare settings.
The affected vials were distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.
Patients and healthcare providers who have these vials should discontinue use and contact Olympia Compounding Pharmacy or their healthcare provider for guidance.
The recalled product
- Product
- Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0097-30
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- 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 (2)
- Lots: L246022 BUD: 6/22/2022
- B24208-22 BUD: 8/8/2022
Distribution
Distributed nationwide across the United States.
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