FDA Recalls Sodium Tetradecyl Sulfate Injection Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 0.3% Injection due to lack of sterilization assurance. The 943 vials of this injectable product were distributed nationwide and may not meet sterile manufacturing requirements.
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 a Class II recall involving a potential sterility failure in an injectable product. While no illnesses or injuries are mentioned in the source, injectable products are inherently high-risk if sterile manufacturing standards are not met, meeting the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy is recalling Sodium Tetradecyl Sulfate 0.3% Injection, 0.3% strength, supplied in 30 mL multi-dose vials. The recall affects 943 vials with lot number B24309-22 and best-use date of 8/9/2022. The product was distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.
The recall was initiated due to lack of assurance of sterility. The manufacturer could not adequately verify that proper sterilization and manufacturing procedures were followed during production. Since sterility is critical for injectable products, this failure represents a potential contamination risk.
This is a Class II recall issued by the FDA under recall number D-0906-2022.
The recalled product
- Product
- Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0121-30
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Injectable / Compounded
- 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: B24309-22 BUD: 8/9/2022
Distribution
Distributed nationwide across the United States.
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