FDAFDA · Food and drugs·Recall number D-0637-2017
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Published April 12, 2017 · Recall initiated: February 8, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- IBUPROFEN LYSINE
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA.
- Lot
- PLND1613, Exp 02/18
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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