FDA DrugsClass II
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fag...
Published: April 15, 2026Recall ID: D-0438-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Product Description & Identification
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
Additional Source Details
| Field | Value |
|---|---|
| City | Wichita |
| State | KS |
| Event id | 98636 |
| Address 1 | 8710 E 34th St N |
| Code info | Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026. |
| Postal code | 67226-2636 |
| Report date | 20260415 |
| Product type | Drugs |
| Product quantity | 25,260 bags |
| Reason for recall | Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260320 |
| Initial firm notification | Letter |
| Center classification date | 20260407 |
Overview
- Recalling FirmFagron Compounding Services
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the U.S.A.