Recall record at a glance
| Official record | D-1798-2019 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Infusion Options, Inc. |
| Report date | Aug 21, 2019 |
| Recall initiation date | Jun 12, 2019 |
| Quantity | N/A |
| Location | Brooklyn, NY, United States |
Official product description
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
Why the product was recalled
Lack of Assurance of Sterility
Distribution information
NY only
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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