US Compounding Recalls Lidocaine Syringes Due to Sterility Assurance Concerns
US Compounding Inc is recalling 7,320 syringes of Lidocaine 1% PF for IV injection because deficient practices may have impacted 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 sterility assurance for an IV injection product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
US Compounding Inc is voluntarily recalling 7,320 syringes of Lidocaine 1% PF (100 mg/10 mL) for IV injection. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and was distributed nationwide. The recall covers specific lots with expiration dates ranging from September 28, 2015, to December 1, 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. This classification is designated as Class II by the FDA.
Healthcare providers and patients who have used or possess these specific syringes should stop using them and contact their healthcare provider or the recalling firm for further instructions. Consumers should not attempt to use the product if they have any concerns about its sterility.
The recalled product
- Product
- Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07
- Manufacturer
- US Compounding Inc
- Affected units
- 7,320
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: 20150104@21 BUD: 9/28/2015
- 20150406@26 BUD: 12/1/2015
- 20151704@1 BUD: 10/14/2015
- 20152004@10 BUD: 10/17/2015
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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