Home / Recalls / X-Gen Pharmaceuticals Inc. / D-0637-2017

D-0637-2017 Class I Terminated

Recalled by X-Gen Pharmaceuticals Inc. — Horseheads, NY

Recall Details

Product Type
Drugs
Report Date
April 12, 2017
Initiation Date
February 8, 2017
Termination Date
June 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2593 cartons

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.

Reason for Recall

Presence of Particulate Matter

Distribution Pattern

Nationwide in the USA.

Code Information

PLND1613, Exp 02/18

Other recalls by X-Gen Pharmaceuticals Inc.

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  • D-0328-2021 Class II — Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manu (March 19, 2021)
  • D-0519-2020 Class III — Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufact (October 11, 2019)
  • D-1084-2019 Class III — Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx (March 29, 2019)
  • D-1059-2017 Class II — Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, R (May 17, 2017)
  • D-1444-2014 Class III — Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx (July 17, 2014)