Recalls / Class II
Class IID-1747-2019
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
- Affected lot / code info
- All lots within expiry
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Infusion Options, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5924 13th Ave, N/A, Brooklyn, New York 11219-4934
Distribution
- Quantity
- N/A
- Distribution pattern
- NY only
Timeline
- Recall initiated
- 2019-06-12
- FDA classified
- 2019-08-15
- Posted by FDA
- 2019-08-21
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1747-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.