The Recall Desk
SevereFDA (Drugs)·D-1105-2015·Announced 2015-06-03

Advanced Physician Solutions Recalls Sodium Tetradecyl Injectable Due to Sterility Concerns

Advanced Physician Solutions is recalling Sodium Tetradecyl Injectable vials nationwide because the company cannot ensure the product is sterile.

What this means for you

Illness, injury, or structural failure has been reported. 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Advanced Physician Solutions, Inc. is recalling Sodium Tetradecyl (Sterile Water) 30ml Vial 2% Injectable. The recall is being conducted because the company lacks assurance of the product's sterility.

The affected product is a 1 vial of Sodium Tetradecyl Injectable manufactured by Advanced Compounding Pharmacy in North Hollywood, California. The recall covers all lots of the product, which were distributed nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to proceed.

The recalled product

Product
SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
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 →