CISPLATIN- cisplatin injection, solution 
Apotex Corp.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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IMPORTANT PRESCRIBING INFORMATION

December 6, 2023

Subject: Temporary Importation of CISplatin Injection (50 mg/50 mL) with non-U.S. Labeling to Address Drug Shortage

Dear Healthcare Professional,

Due to the critical shortage of CISplatin Injection in the United States (U.S.), Qilu Pharmaceutical Co. Ltd (Qilu), in conjunction with Apotex Corp., is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. Qilu has initiated temporary importation of CISplatin Injection (50 mg/50 mL) with vial and carton labels in Chinese into the U.S. market. The CISplatin Injection from Qilu is marketed and manufactured in China and is not FDA-approved.

Only Qilu or its distributor, Apotex Corp., is authorized by the FDA to import or distribute Qilu's CISplatin Injection in the United States.

Effective immediately and during this temporary period, Apotex Corp. will distribute the following presentation of CISplatin Injection to address the critical shortage:

Product NameQuantityDescriptionU.S. NDC NumberLot NumberExpiration Date
CISplatin Injection (50 mg/50 mL)1 vial per cartonColorless to yellowish clear liquid

Each 1 mL contains 1 mg of CISplatin and 9 mg of Sodium Chloride in water for injection.
60505-6277-0

See Appendix 1 for a scannable linear barcode readable by U.S. scanning systems.
3J025C882025-09-26
3J026C882025-09-26
3J027C882025-09-26
3K028C882025-10-08
3K029C882025-10-08
3K030C882025-10-08
3K031C882025-10-09
3K032C882025-10-09
3K033C882025-10-09
3K034C882025-10-11
3K035C882025-10-11
3K036C882025-10-11

It is important to note the following:

CISplatin injection is available only by prescription in the U.S. The imported lots did not have the statement “Rx only” on their labeling. This information is included on the sticker noted in the bullet above.

The carton of the imported product does not include a product identifier. Specifically, each package of product does not include the NDC, unique serial number, lot number, and expiration date in both human-readable form and a two-dimensional data matrix barcode.

Please refer to the package insert for the FDA-approved CISplatin Injection drug product for full prescribing information.

Finally, please ensure that your staff and others in your institution who may be involved in the administration of CISplatin Injection receive a copy of this letter and review the information.

If you have any questionsabout the information contained in this letter, any quality related problems, or questions on the use of Qilu’s CISplatin Injection, please contact Apotex Corp. Customer Service at 1-800-706-5575.

For ordering information, please contact your primary wholesaler or distributor to place an order with Apotex Corp. at 1-800-706-5575.

Healthcare providers should report adverse events associated with the use of Qilu’s CISplatin Injection to Apotex Corp. at 1-800-706-5575.

Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:

We remain at your disposal to answer any questions you may have about our product; and provide more information if needed.

Sincerely,

sign

Mr. Yin Xunliao

Deputy General Manager

Qilu Pharmaceutical Co., Ltd.

Enclosures:
Appendix 1 – Barcodes for Pharmacy Dispensing
Appendix 2 – Product Label and Product Characteristics Side-by-Side Comparison Table
Appendix 3 – Prescribing Information Side-by-Side Comparison Table
Available at www1.apotex.com/us/CISplatin_Injection

Appendix 1: Barcode for Pharmacy Dispensing

appendix-1

Appendix 2: Product Label and Product Characteristics Side-by-Side Comparison Table

appendix-2-1appendix-2-2appendix-2-3

Appendix 3: Prescribing Information Side-by-Side Comparison Table (translated from Chinese)

appendix-3-1appendix-3-2appendix-3-3appendix-3-4appendix-3-5appendix-3-6appendix-3-7appendix-3-8appendix-3-9appendix-3-10appendix-3-11appendix-3-12appendix-3-13appendix-3-14appendix-3-15appendix-3-16appendix-3-17appendix-3-18appendix-3-19appendix-3-20appendix-3-21appendix-3-22appendix-3-23appendix-3-24

DHCP version: 34040099636B

NDC 60505-6277-0

Stop! Verify Drug Name and Dose!

CISplatin Injection

50 mg/50 mL (1 mg/mL). Rx Only.

CISplatin doses greater than 100 mg/m once every 3 to 4 weeks are rarely used. See letter.

sticker-1sticker-2

CISPLATIN 
cisplatin injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60505-6277
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CISPLATIN (UNII: Q20Q21Q62J) (CISPLATIN - UNII:Q20Q21Q62J) CISPLATIN50 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60505-6277-01 in 1 CARTON06/06/2023
150 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage06/06/2023
Labeler - Apotex Corp. (845263701)
Establishment
NameAddressID/FEIBusiness Operations
Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)544532200manufacture(60505-6277) , analysis(60505-6277) , pack(60505-6277)

Revised: 12/2023
Document Id: 0d0f8dab-8203-e3f8-e063-6294a90ab1d3
Set id: be185d9c-d82f-442b-81db-348e3715e7a4
Version: 4
Effective Time: 20231221
 
Apotex Corp.