FDA Recalls Sodium Tetradecyl Sulfate Syringes Due to Sterility Concerns
FDA is recalling 100 syringes of Sodium Tetradecyl Sulfate Injectable Solution 3% due to lack of assurance of sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug poses a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Sodium Tetradecyl Sulfate, Injectable Solution, 3%, 2 mL syringes. The recall involves 100 syringes manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The product is prescription-only and was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that this issue affects all sterile human compounded drugs within their expiry date. No specific illnesses or injuries have been reported in the provided text.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The recall code is 06152015@10.
The recalled product
- Product
- SODIUM TETRADECYL SULFATE, Injectable Solution, 3%, 2 mL syringe, Rx only, JD & SN Inc, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
- Category
- Drug — Injectable Solution
- Affected units
- 100
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)
- 06152015@10
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional 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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