FDA Drug recall 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 car…
- FDA Drug
- Class I
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class I recall of 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 car… by X Gen Pharmaceuticals, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0637-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-02-08 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | X Gen Pharmaceuticals |
| Distribution | US |
Product
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
Presence of Particulate Matter
Identifiers
| ndc | 39822-1030-1 |
|---|---|
| ndc | 39822-1030-2 |
| code_info | PLND1613, Exp 02/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0637-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.