Drug FDA Class II Terminated Failed specifications

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

ACCORD HEALTHCARE, INC. Published Oct 23, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact ACCORD HEALTHCARE, INC. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed Impurities/Degradation Specifications.

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

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

CISPLATIN · 11,214 vials

NDC: 16729-288, 16729-288-11, 16729-288-38

Code info: Lot #: P2202009, Exp. Date: 03/2025

Affected areas

Nationwide

Timeline

Initiated

Oct 1, 2024
Published

Oct 23, 2024
Terminated

Feb 23, 2026

Recall number: D-0010-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.