Recalls / Class II
Class IID-1798-2019
Product
PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG / 500 ML NS IVPB; PACLITAXEL 340 MG / 500 ML NS IVPB; PACLITAXEL 332 MG / 500 ML NS IVPB; PACLITAXEL 250 MG / 500 ML NS IVPB; PACLITAXEL 117 MG / 250 ML NACL 0.9% IVPB PACLITAXEL 90 MG / 250 ML NS IVPB; PACLITAXEL 290 MG / 500 ML NS IVPB; PACLITAXEL 168 MG / 250 ML NS IVPB; PACLITAXEL 157 MG / 250 ML NS IVPB; PACLITAXEL 350 MG / 500 ML NS IVPB; PACLITAXEL 280 mg / 500 ML NS IVPB; PACLITAXEL 282 mg / 500 ML NS IVPB; PACLITAXEL 90 MG / 250 ML D5W IVPB; PACLITAXEL 255 MG / 500 ML NS IVPB; PACLITAXEL 100 MG / 250 ML NS IVPB; PACLITAXEL 80 MG / 250 ML D5W IVPB; PACLITAXEL 117 MG / 250 ML NS IVPB; PACLITAXEL 159 MG / 250 ML NS IVPB; PACLITAXEL 330 MG / 500 ML NS IVPB; PACLITAXEL135 MG / 250 ML NS IVPB; PACLITAXEL 200 MG / 500 ML NS IVPB; PACLITAXEL 150 MG / 250 ML NS IVPB; PACLITAXEL 130 MG / 250 ML NS IVPB; PACLITAXEL 144 MG / 250 ML NS IVPB; PACLITAXEL 300 MG / 500 ML NS IVPB; PACLITAXEL 120 MG / 250 ML NS IVPB; PACLITAXEL 140 MG / 250 ML NS 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-1798-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.