Drug product
ADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB 242 MG/250 ml NS; ADO-TRASTUZUMAB EMT 168 mg / 250 ml NS; ADO-TRASTUZUMAB E 160 MG / 250 ML NS ADO-TRASTUZUMAB 150 mg / 250 ml NS; ADO-TRASTUZUMAB EMT 301 mg / 250 ml NS; ADO-TRASTUZUMAB EMTANSINE 230mg/250ml NS IV Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
D-1747-2019
Product summary
- Event
- Event 83136
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1747-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within expiry
Distribution pattern: NY only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility