Class II · Moderate risk Terminated
Cisplatin Active Pharmaceutical Ingredient
Reason cGMP Deviations: Potential glass contamination
Cisplatin Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications.
What was recalled
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38
- Recalling firm
- Accord Healthcare, INC.
- NDC code
- 16729-288-38
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0010-2025
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.
Other Cisplatin recalls
See all
Class II · Moderate risk Terminated
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cisplatin active pharmaceutical ingredient packaged in varying…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk Terminated
Cisplatin 1mg/Ml Injectable 1000 Ml
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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