Advanced Compounding Pharmacy Recalls Sodium Tetradecyl Sulfate Injectable
Advanced Physician Solutions, Inc. is recalling Sodium Tetradecyl Sulfate (Sterile Water) 3.5% Injectable due to a 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with non-sterile injectable products.
Plain-English summary
Advanced Physician Solutions, Inc. is recalling Sodium Tetradecyl Sulfate (Sterile Water) (30ML) 3.5% Injectable, manufactured by Advanced Compounding Pharmacy in North Hollywood, California. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is a 1 vial of 3.5% Sodium Tetradecyl Sulfate in Sterile Water. The recall covers all lots of this product. The distribution pattern is listed as nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
- Manufacturer
- Advanced Physician Solutions, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Advanced Physician Solutions, Inc. 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 18 products in this recall →Related recalls
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