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.
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 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
- Manufacturer
- Advanced Physician Solutions, Inc.
- Category
- Drug — Injectable
- Hazard
- 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 →Related recalls
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