Drug product
HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; HERCEPTIN 553 MG / 250 ml NS IVPB; HERCEPTIN 305 MG / 250 ml NS IVPB; HERCEPTIN 526 MG / 250 ML NS IVPB; HERCEPTIN 162 MG / 250 ML NS IVPB; HERCEPTIN 354 MG/ 250 ml 0.9% NACL IVPB; HERCEPTIN 440 MG / 250 ML NS IVPB; HERCEPTIN 650 MG / 250 ML NS IVPB; HERCEPTIN 472 MG / 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
D-1783-2019
Product summary
- Event
- Event 83136
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1783-2019
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