Polymyxin B for Injection Recalled Due to Particulate Matter Contamination
AuroMedics Pharma LLC is recalling Polymyxin B for Injection USP (Lot CPB200013) nationwide due to the presence of particulate matter, including hair, found in vials.
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: This recall is classified by the FDA as Class I. Under the severity rubric, FDA Class I recalls must not be scored below 4. Although no illnesses or injuries are explicitly reported in the source text, the injectable nature of the product and the presence of particulate contamination (including foreign material such as hair) in a sterile pharmaceutical creates significant potential for serious harm.
Plain-English summary
AuroMedics Pharma LLC is recalling 35,520 vials of Polymyxin B for Injection USP, 500,000 Units per Vial, in 10 mL vials (NDC 55150-234-10, Lot CPB200013, expiration 9/2022). The recall was initiated due to the presence of particulate matter in the product, with a product complaint specifically reporting hair discovered in a vial.
Polymyxin B for Injection is a prescription antibiotic administered by intramuscular, intrathecal, intravenous, or ophthalmic routes. The affected lot was distributed nationwide in the United States.
Patients and healthcare providers who have this product should stop using it immediately and contact their healthcare provider or pharmacy. The FDA has classified this recall as Class I, indicating a serious health hazard.
The recalled product
- Product
- POLYMYXIN B (POLYMYXIN B)
- Brand
- POLYMYXIN B
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Injectable Antibiotic
- Hazard
- particulate-contamination
- foreign-material
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 (2)
- Lot CPB200013
- exp 9/2022
UPCs (1)
- 0355150234103
Distribution
Distributed nationwide across the United States.
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