Sodium Tetradecyl Sulfate Injection Recalled for Lack of Sterility Assurance
Olympia Pharmacy is recalling 588 vials of Sodium Tetradecyl Sulfate 5% injection nationwide due to inability to assure product sterility. The multi-dose vials carry a potential contamination risk for patients.
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 medication. Sterility assurance failure in injectable drugs represents a risk-of-harm product scenario per the severity rubric, placing it in the High category.
Plain-English summary
Olympia Compounding Pharmacy is recalling 588 vials of Sodium Tetradecyl Sulfate 5% MDV (multi-dose vial) injection due to lack of assurance of sterility. The affected product is NDC 73198-0102-05, Lot L24306, with a Breakdown Date of June 6, 2022.
The product was distributed nationwide throughout the United States, Puerto Rico, and the U.S. Virgin Islands. Sodium Tetradecyl Sulfate is a prescription medication used for injection; inability to assure sterility in injectable medications presents a potential contamination risk.
Patients currently using this product should consult their healthcare provider immediately. Healthcare providers and patients should not use vials from the identified lot number and should contact Olympia Pharmacy or their healthcare provider for replacement medication or further guidance.
The recalled product
- Product
- Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0102-05
- Category
- Drug
- Hazard
- Affected units
- 588
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: L24306 BUD: 6/6/2022
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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