FDA Drug recall D-1815-2019
TRASTUZUMAB 427 MG / 250 ml NS IVPB
- FDA Drug
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of TRASTUZUMAB 427 MG / 250 ml NS IVPB by Infusion Options, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1815-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-12 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Infusion Options |
| Distribution | NY |
Product
TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG / 250 ML NS IVPB; TRASTUZUMAB 444 MG / 250 ml NS IVPB; TRASTUZUMAB 634 MG / 250 ML NS IVPB; TRASTUZUMAB 330 MG / 250 ML NS IVPB; TRASTUZUMAB 781 MG / 250 ML NS IVPB; TRASTUZUMAB 376 mg / 250 ML NS IVPB; TRASTUZUMAB 114 MG / 250 ML NS IVPB; TRASTUZUMAB 266 MG / 250 ML NS IVPB TRASTUZUMAB 323 MG / 250 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | All lots within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1815-2019%22
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