Drug 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
D-1815-2019
Product summary
- Event
- Event 83136
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1815-2019
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