US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns
US Compounding Inc is recalling 105 syringes of Hyaluronic Acid/Lidocaine due to deficient practices that may impact sterility assurance.
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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
US Compounding Inc is recalling 105 single-use syringes of Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL) for intra-articular injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and was distributed nationwide.
The recall was initiated because of deficient practices that may have an impact on sterility assurance. The firm is recalling all sterile preparations that are within expiry due to these concerns.
Affected lot numbers include 20151806@30, 20152306@38, 20151806@29, and 20151903@30. The expiration dates for these lots are 11/7/2015 and 9/15/2015. Consumers and healthcare providers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
- Manufacturer
- US Compounding Inc
- Affected units
- 105
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 (4)
- Lot Numbers: 20151806@30 BUD: 11/7/2015
- 20152306@38 BUD: 11/7/2015
- 20151806@29 BUD: 11/7/2015
- 20151903@30 BUD: 9/15/2015
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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