Class II · Moderate risk
PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB
Lack of Assurance of Sterility
Paclitaxel Protein 175 Mg/100 Ml Ns Ivpb
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 355 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Drug: Paclitaxel
- Recalling firm
- Infusion Options, Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1800-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Paclitaxel recalls
See all
Class II · Moderate risk
Paclitaxel 258 Mg / 500 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Paclitaxel Semi-Synthetic active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Paclitaxel Injection
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Class II · Moderate risk
Paclitaxel Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Other recalls by Infusion Options, Inc.
All 2019 recalls
Class II · Moderate risk
FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Vincristine 1 Mg /50 Ml Ns Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
Vinblastine 10.9 Mg / 100 Ml D5w Ivpb
Lack of Assurance of Sterility
Class II · Moderate risk
VELCADE 2.1 mg / 0.84 ml SQ SYRINGE
Lack of Assurance of Sterility
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