Class II · Moderate risk Terminated
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…
Reason Lack of Assurance of Sterility
PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
What was recalled
PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India
- Recalling firm
- Fresenius Kabi USA, LLC
- NDC code
- 63323-763-50
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-016-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Class II · Moderate risk Terminated
PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB; PACLITAXEL ALBUMIN 160 MG / 100 ml NS IVPB; PACLITAXEL ALBUMIN 145 MG / 100 ml NS IVPB…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG / 500 ML NS IVPB; PACLITAXEL 340 MG /…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Paclitaxel Semi-Synthetic active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc…
Reason The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to…
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