Mylan Recalls Carboplatin Injection Due to Particulate Matter
Mylan Institutional LLC is recalling Carboplatin Injection 450 mg/45 mL due to the presence of particulate matter.
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: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric.
Plain-English summary
Mylan Institutional LLC is recalling Carboplatin Injection 450 mg/45 mL (10 mg/mL), packaged in a 100 mL Multi-Dose Vial. The recall is being conducted because of the presence of particulate matter in the product.
The affected product is identified by Lot # 7801312 and has an expiration date of 06/15. A total of 4,445 vials were distributed nationwide. The product is manufactured for Mylan Institutional LLC in Rockford, IL, and made in India.
Healthcare providers and patients should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 4,445
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 #: 7801312
- Exp 06/15
Distribution
Distributed nationwide across the United States.
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