Sodium Bicarbonate 8.4% Injectable Recalled Over Sterility Assurance Concerns
Olympia Compounding Pharmacy is recalling 1,466 vials of Sodium Bicarbonate 8.4% Multi-Dose Injectable (Lot L41002) due to lack of assurance of sterility. The product was distributed nationwide.
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: This is an FDA Class II recall of an injectable drug with a potential sterility defect. Although no illnesses or injuries have been reported and the hazard remains theoretical, the product is an injectable medication where sterility failure could cause serious infection, meeting the criterion for risk-of-harm products without reported injury.
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling Sodium Bicarbonate 8.4% Multi-Dose Injectable, 30 mL vials. The recall affects 1,466 vials (Lot L41002, BUD 6/2/2022) distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
The product is being recalled due to lack of assurance of sterility. Sterility is critical for injectable medications administered intravenously. Healthcare facilities and providers who received this lot should cease use immediately.
No illnesses or injuries have been reported to date. Patients or healthcare providers with questions about this product should contact Olympia Compounding Pharmacy at 6700 Conroy Rd., Suite 155, Orlando, FL 32835, or consult their healthcare provider.
The recalled product
- Product
- Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,466
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: L41002 BUD: 6/2/2022
Distribution
Part of a larger recall action
This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy 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.
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