Eagle Pharmaceuticals Recalls Argatroban Injection Due to Visible Particulates
Eagle Pharmaceuticals is recalling specific lots of Argatroban Injection after a hospital reported crystalline particulates and fibers in a vial.
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 use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls must be scored at least 4.
Plain-English summary
Eagle Pharmaceuticals, Inc. is recalling specific lots of Argatroban Injection 50 mg per 50ml. The recall was initiated after a complaint was received from a hospital pharmacy on November 10, 2011, regarding crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were also identified in the product.
The affected product is Argatroban Injection 50 mg per 50ml (1 mg per ml) for intravenous infusion only. The recall covers 19,660 vials distributed in New Jersey. The specific lots affected are Lot #V10189, Lot #V10191, and Lot #V10194 (Expiration 01/13), and Lot #V10223 (Expiration 02/13). The product is manufactured by Cipla LTD, India, for Eagle Pharmaceuticals, Inc., and marketed by The Medicines Company.
Healthcare providers and patients should stop using the affected lots of Argatroban Injection and contact their healthcare provider or the manufacturer for further instructions. This recall is classified as Class I by the FDA.
The recalled product
- Product
- Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ…
- Manufacturer
- Eagle Pharmaceuticals Inc.
- Category
- Drug — Injectable
- Affected units
- 19,660
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 (6)
- Lot #V10189
- Lot #V10191
- Lot #V10194
- Exp 01/13
- Lot #V10223
- Exp 02/13
Distribution
Distributed in 1 state:
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