US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns
US Compounding Inc is recalling 5,118 syringes of Hyaluronic Acid/Lidocaine PF due to deficient practices that may impact sterility assurance.
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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk structural defects in medical products.
Plain-English summary
US Compounding Inc is recalling 5,118 syringes of Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe, For Intra-Articular Injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is available by prescription only. The recall covers specific lot numbers with expiration dates ranging from October 2015 to December 2015.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry. The affected products were distributed nationwide.
Consumers and healthcare providers should stop using the recalled syringes and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Compounded Injectable
- Affected units
- 5,118
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 (5)
- Lot Numbers: 20150906@32 BUD: 12/6/2015
- 20150906@33 BUD: 12/6/2015
- 20151105@45 BUD: 11/7/2015
- 20151205@12 BUD: 11/8/2015
- 20151404@39 BUD: 10/11/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding 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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