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Class II · ModerateRecall completed

Cisplatin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: P2202009, Exp. Date: 03/2025
Where it was soldNationwide within the United States and PR
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336 foreign manufacturer
Brand nameCISPLATIN
Generic nameCISPLATIN
Active ingredient(s)CISPLATIN
Distributed by / forAccord Healthcare Inc., Durham, NC 27703
NDC16729-288-38
Show the full FDA record
Full product labelCisplatin 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 firmACCORD HEALTHCARE, INC.
DistributionNationwide within the United States and PR
Quantity11,214 vials
Recall initiated2024-10-01
Report date2024-10-23
Recall completed2026-02-23
Recall numberD-0010-2025
ClassificationClass II
FDA statusTerminated
Origin on fileRaleigh NC United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.