Class II · Moderate risk
Cisplatin Active Pharmaceutical Ingredient
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.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
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
Affected NDC
16729-0288-38
Compare with the code on your package — it is the most precise check available.
Drug: Cisplatin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cisplatin NDC 16729-0288 |
1 mg/mL | Injection Intravenous |
Accord Healthcare Inc. | Rx |
- 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 · 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 Cisplatin recalls
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Class II · Moderate risk
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G
Lack of Assurance of Sterility
Class II · Moderate risk
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G
Lack of Assurance of Sterility
Class II · Moderate risk
Cisplatin active pharmaceutical ingredient packaged in varying…
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
Cisplatin 1mg/Ml Injectable 1000 Ml
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.
Other recalls by Accord Healthcare, INC.
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