Class II · Moderate risk Terminated
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord…
Reason Failed Impurities/Degradation Specifications.
Cisplatin 1mg/Ml Injectable 1000 Ml, 2000 Ml (2 Different Products)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1485-2012
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 Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ…
Reason cGMP Deviations: Potential glass contamination
Class II · Moderate risk Terminated
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cisplatin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
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…
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.