FDA Recalls Sodium Tetradecyl Sulfate Injectable Over Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 1.5% Injection (480 vials, Lot B24308-22) due to lack of assurance of sterility. The injectable was 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 injectable drug carries inherent risk of serious harm if sterility cannot be assured, fitting the criterion of 'risk-of-harm products where injury has not yet been reported.' The FDA Class II classification indicates potential for adverse health consequences. No illnesses or injuries are reported in the source.
Plain-English summary
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 1.5% MDV Injection, supplied in 30 mL multi-dose vials. The recall affects 480 vials of Lot B24308-22 with a beyond-use date of August 8, 2022, identified by NDC 73198-0122-30.
The FDA classified this as a Class II recall due to lack of assurance of sterility. Injectable medications must meet strict sterility standards to prevent microbial contamination. The affected product was distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.
Healthcare providers and patients with this medication should stop use immediately and contact their pharmacy or healthcare provider. Anyone who has used this product and experiences signs of infection should seek medical attention. Return the medication to the pharmacy for proper disposal rather than discarding it.
The recalled product
- Product
- Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0122-30
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- 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)
- Lot: B24308-22 BUD: 8/8/2022
Distribution
Distributed nationwide across the United States.
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