Mylan Recalls Cytarabine Injection Vials Due to Particulate Matter
Mylan Institutional LLC is recalling 8,340 vials of Cytarabine Injection due to the presence of particulate matter. The affected product was distributed nationwide.
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 recall is classified as FDA Class I, which indicates a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.
Plain-English summary
Mylan Institutional LLC is recalling 8,340 vials of Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02). The recall is being conducted due to the presence of particulate matter in the product.
The affected product is identified by Lot # 7801050 and has an expiration date of 05/2015. The product is distributed by Pfizer Labs, Division of Pfizer Inc., and was available nationwide. It is a prescription-only medication.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. Consumers should not use the product if they have any questions regarding its safety.
The recalled product
- Product
- Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 8,340
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 # 7801050
- Exp. Date. 05/2015
Distribution
Distributed nationwide across the United States.
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