Advanced Physician Solutions Recalls Sodium Hyaluronate Vials Due to Sterility Concerns
Advanced Physician Solutions is recalling 21 vials of Sodium Hyaluronate Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable product corresponds to a severity score of 4 (Severe).
Plain-English summary
Advanced Physician Solutions, Inc. is recalling 21 vials of Sodium Hyaluronate (Sterile Water) 2.5 ML Vial 20MG/ML Injectable. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product was manufactured by Advanced Compounding Pharmacy located in North Hollywood, California. The recall covers all lots of the product, which was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product immediately. They should contact Advanced Physician Solutions, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
- Manufacturer
- Advanced Physician Solutions, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 21
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.
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