Shionogi Inc.
Shionogi Inc. lists 7 drug products in the FDA National Drug Code directory.
Products
| NDC | Product | Strength | Type |
|---|---|---|---|
| 59630-266 | Fetroja Injection, Powder, For Solution | Cefiderocol Sulfate Tosylate 1 g/10mL | Rx |
| 59630-750 | Methylin Solution | Methylphenidate Hydrochloride 5 mg/5mL | Rx |
| 59630-755 | Methylin Solution | Methylphenidate Hydrochloride 10 mg/5mL | Rx |
| 59630-551 | Mulpleta Tablet, Film Coated | Lusutrombopag 3 mg/1 | Rx |
| 70510-2321 | Radicava Ors Kit | Rx | |
| 70510-2322 | Radicava Ors Kit | Rx | |
| 59630-711 | Xocova Tablet | Ensitrelvir 125 mg/1 | Rx |
Recalls by Shionogi Inc.
- D-0219-2018 Jan 24, 2018 · Class III
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules - D-0982-2017 Jul 26, 2017 · Class III
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing - D-0981-2017 Jul 26, 2017 · Class III
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing - D-1284-2015 Aug 12, 2015 · Class III
Failed Dissolution Specifications - D-1398-2012 Jul 4, 2012 · Class II
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point