Why it was recalled
Presence of Particulate Matter
Product description
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.
Lot numbers, UPCs & expiration codes
PLND1613, Exp 02/18
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0637-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 8, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- 2593 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- X-Gen Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0637-2017, exactly as published.
Show all FDA fields
- City
- Horseheads
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 76410
- Address
- 300 Daniel Zenker Dr
- Code information
- PLND1613, Exp 02/18
- Postal code
- 14845-1014
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0637-2017
- Classification
- Class I
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Product quantity
- 2593 cartons
- Termination date
- Jun 10, 2020
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Feb 8, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 5, 2017