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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 35,520
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.
Related recalls
Same manufacturer · AuroMedics Pharma LLC
See all →- HighFondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation
FDA (Drugs) · 2022-11-02
- HighAcyclovir Sodium Injectable Recalled for Particulate Matter
FDA (Drugs) · 2022-10-26
- LowTranexamic Acid Injection Recalled for Metal Particulate Matter
FDA (Drugs) · 2022-10-12
- SevereAuroMedics Recalls Acetaminophen Injection Due to Discoloration and pH Failures
FDA (Drugs) · 2021-02-10
- ModerateAuroMedics Recalls Glycopyrrolate Injection Due to Benzaldehyde Impurity
FDA (Drugs) · 2020-02-26
Same hazard · particulate contamination
See all →- CriticalCardiovascular Procedure Kits Recalled Due to Particulate in Fluid Path
FDA (Devices) · 2026-08-05
- HighLidocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateFDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- SevereMedline Medical Convenience Kits with Namic Manifold Fluid Contamination
FDA (Devices) · 2026-05-20
- SevereMedline Medical Convenience Kits with Namic Manifold recalled
FDA (Devices) · 2026-05-20
Similar recalls
- SevereAuroMedics Recalls Piperacillin and Tazobactam Injection Vials Due to Particulate Matter
FDA (Drugs) · 2018-07-18
- SevereDrug recall: Bleomycin injection vials recalled due to glass contamination
FDA (Drugs) · 2024-01-31
- SevereAuroMedics Recalls Ampicillin and Sulbactam Injection Due to Particulate Matter
FDA (Drugs) · 2018-05-16
- CriticalAuroMedics Recalls Piperacillin and Tazobactam Injection Due to Glass Particulates
FDA (Drugs) · 2018-05-23
- LowAuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter
FDA (Drugs) · 2019-12-04
- SevereAurobindo Recalls MARBETA L KIT Vials Due to Particulate Matter
FDA (Drugs) · 2019-04-17