US Compounding Recalls Lincomycin/Lidocaine Vials Due to Sterility Concerns
US Compounding Inc is recalling 1,421 vials of Lincomycin/Lidocaine due to deficient practices that may impact sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure in IV medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
US Compounding Inc is recalling 1,421 vials of Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, for IV Injection or IV Injection After Dilution. The product was compounded by US Compounding Pharmacy in Conway, Arkansas, and distributed nationwide. The specific lot number is 20150505@1 with a beyond-use date of 10/31/2015.
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 period. This is an FDA Class II recall.
Patients who have received this medication should consult their healthcare provider. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3104-07
- Manufacturer
- US Compounding Inc
- Category
- Drug — Compounded Injectable
- Affected units
- 1,421
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: 20150505@1 BUD: 10/31/2015
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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