Sodium Selenite Injectable Vials Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy recalls 2,333 vials of Sodium Selenite 200 mg/mL injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA, Puerto Rico, and the U.S. Virgin Islands.
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 of an injectable pharmaceutical product where sterility assurance failed, meeting the criterion of a risk-of-harm product where injury has not yet been reported. No illnesses or injuries have been reported in the source text.
Plain-English summary
Olympia Compounding Pharmacy is recalling Sodium Selenite 200 mg/mL injectable vials due to a lack of assurance of sterility. Approximately 2,333 vials were distributed nationwide in the USA, Puerto Rico, and the U.S. Virgin Islands.
The affected lots are L24014 (beyond-use date 6/14/2022) and B24024-22 (beyond-use date 8/24/2022). The product is manufactured by Olympia Compounding Pharmacy at 6700 Conroy Rd., Suite 155, Orlando, FL 32835.
Healthcare providers and patients who have received this product should not use it. Contact Olympia Compounding Pharmacy for instructions on how to return the product and obtain a replacement.
The recalled product
- Product
- Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0074-30
- Category
- Drug — Injectable / Compounded
- Affected units
- 2,333
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: L24014 BUD: 6/14/2022
- B24024-22 BUD: 8/24/2022
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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