Agency classClass IIOur severity:High FDA (Drugs)·D-0907-2022·Announced 2022-06-01

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.

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 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
Affected units: 480

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.

The notice also names 2 states specifically:

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.

See all 53 products in this recall →

Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy

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