X-Gen Recalls Ibuprofen Lysine Injection Due to Particulate Matter
X-Gen Pharmaceuticals is recalling 2,593 cartons of Ibuprofen Lysine Injection because of the presence of particulate matter. The affected product was distributed nationwide in the USA.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criterion for a Critical severity score of 5.
Plain-English summary
X-Gen Pharmaceuticals Inc. is recalling 2,593 cartons of Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial. The recall is being conducted due to the presence of particulate matter in the product. The affected product is identified by lot number PLND1613 and expiration date 02/18.
The recalled product is a prescription-only intravenous injection distributed nationwide in the USA. It is packaged in 3 x 2 mL Single-Dose Vials per carton. The product was manufactured by Exela Pharma Sciences, LLC, and distributed by X-Gen Pharmaceuticals, Inc.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- IBUPROFEN LYSINE (IBUPROFEN LYSINE)
- Brand
- IBUPROFEN LYSINE
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 2,593
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)
- PLND1613
- Exp 02/18
Distribution
Distributed nationwide across the United States.
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