AuroMedics Pharma recalls Polymyxin B for Injection due to hair discovered in vials. This sterile prescription drug (NDC 55150-234-10) may contain particulate matter. Affected lots: CPB200013 (exp 9/2022).
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
AuroMedics Pharma is recalling Polymyxin B for Injection vials that may contain hair or other particles. This could cause serious injury if injected, so affected users should stop using the product immediately.
The product contains particulate matter, including hair, which can cause serious injury if injected. This is a known issue with the specific lot of vials that were distributed.
Prescription drug users who received Polymyxin B for Injection vials with lot number CPB200013 (expiring 9/2022) from AuroMedics. Patients using this medication for medical treatment are most at risk.
Check for vials labeled 'Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL' with lot number CPB200013 (expiring 9/2022). The product is sterile and prescription-only.
Immediately stop using the recalled Polymyxin B for Injection vials with lot number CPB200013.
No, the product may contain hair or other particles that could cause serious injury if injected. Do not use this lot.
Stop using it immediately and contact your healthcare provider for alternative treatment.
Look for vials labeled 'Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL' with lot number CPB200013 (expiring 9/2022).
We’ve drafted a message you can send AuroMedics to request your refund or repair — edit it as you like.
Subject: Recall D-0556-2022 — AuroMedics AuroMedics Hello, I own a AuroMedics that is covered by recall D-0556-2022 from AuroMedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
