The Recall Desk
SevereFDA (Drugs)·D-1103-2015·Announced 2015-06-03

Advanced Physician Solutions Recalls Sodium Hyaluronate Syringes Due to Sterility Concerns

Advanced Physician Solutions is recalling 416 prefilled syringes of Sodium Hyaluronate Injectable because the company cannot guarantee 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile injectable products.

Plain-English summary

Advanced Physician Solutions, Inc. is recalling 416 prefilled syringes of Sodium Hyaluronate (2ml) Sterile Water 20mg/ml Injectable. The product was manufactured by Advanced Compounding Pharmacy in North Hollywood, California, and distributed nationwide. The recall covers all lots of the product.

The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot confirm that the injectable product is free from microbial contamination.

Consumers and healthcare providers who have this product should stop using it and contact Advanced Physician Solutions, Inc. for instructions on how to return or dispose of the syringes.

The recalled product

Product
SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Affected units
416

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 →