US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns
US Compounding Inc is recalling 531 hyaluronic acid and lidocaine syringes because deficient practices may have impacted 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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a risk of serious health consequences (sterility failure in an injectable product) corresponds to a severity score of 4 (Severe), particularly given the potential for significant injury from non-sterile injections.
Plain-English summary
US Compounding Inc is recalling 531 single-use syringes of Hyaluronic Acid/Lidocaine PF (60 mg/2%) for intra-articular injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and carries the NDC 62295-3249-03. The specific lot number is 20151105@39, with a beyond-use date of 11/7/2015.
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 distribution of the affected product was nationwide.
Consumers and healthcare providers should stop using the affected syringes and contact their healthcare provider or the recalling firm for further instructions. The product is prescription-only and intended for intra-articular injection.
The recalled product
- Product
- Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03
- Manufacturer
- US Compounding Inc
- Category
- Drug — Compounded Injectable
- Affected units
- 531
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)
- Lot Numbers: 20151105@39 BUD: 11/7/2015
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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