Recalls / Class II
Class IID-1797-2019
Product
OXALIPLATIN 145 MG /250 ML D5W IVPB; OXALIPLATIN 154 MG / 250 ML D5W IVPB; OXALIPLATIN 130 MG / 250 ML D5W IVPB; OXALIPLATIN 140 MG / 250 ml D5W IVPB; OXALIPLATIN 162 MG / 250 ML D5W IVPB; OXALIPLATIN 169 MG / 250 ML D5W IVPB; OXALIPLATIN 90 MG / 500 ML D5W IVPB; OXALIPLATIN 50 MG / 250 ML D5W IVPB; OXALIPLATIN 70 MG / 500 ML D5W IVPB; OXALIPLATIN 40 MG / 250 ML D5W IVPB; OXALIPLATIN 155 MG / 250 ML D5W IVPB; OXALIPLATIN 85 MG / 250 ML D5W IVPB OXALIPLATIN 146 MG / 250 ML D5W IVPB; OXALIPLATIN 246 MG / 500 ML D5W IVPB; OXALIPLATIN 143 MG / 250 ML D5W IVPB; OXALIPLATIN 65 MG / 500 ML D5W IVPB; OXALIPLATIN 80 MG / 500 ML D5W IVPB; OXALIPLATIN 100 MG / 250 ML D5W IVPB; OXALIPLATIN 150 MG / 250 ML D5W IVPB; OXALIPLATIN 125 MG / 250 ML D5W IVPB; OXALIPLATIN 170 MG / 250 ML D5W IVPB, 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-1797-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.