Ready-to-administer injectables

Midazolam Injection USP

RE: Midazolam Injection USP 1mg/mL in 100 mL ready-to-use bags – DIN 02498022 – GTIN: 07540178000349

Dear Customers,

 

We wish to inform you that the content of the GTIN in the GS1 DataMatrix barcodes of our Midazolam Injection USP 1mg / mL ready to use bags in 100 mL, product code FBCA4003F, is incorrect (see the red circle in the image opposite).

 

The GTIN in the GS1 DataMatrix barcode of Midazolam Injection USP 1mg / mL ready-to-use bags in 100 mL matches that of the Morphine Sulfate Injection USP 1 mg / mL in 100 mL bags, product code FBCA4006F.

 

Table 1– Impacted lots

Lot Number

Expiry Date

20293201

2022-06-30

20323201

2022-07-31

20373201

2022-08-31

20383201

2022-08-31

20443201

2022-09-30

20461202

2022-10-31

20481203

2022-10-31

 

 

Using the information in this barcode without verifying the clear readable information could result in medication errors. Therefore, we ask you not to use the GS1 DataMatrix barcode that appears in the red circle above of the Midazolam bags for the above lots.

 

The information contained in the GS1 DataMatrix barcode on the overwrap and the GS1 DataBar on the overwrap and on the bag presents the correct information. The rest of the information that appears on the bag and on the overwrap is correct.

 

We apologize for the inconvenience associated with this situation. If you have any questions regarding this situation, please contact our Medical Information Department at MEDINFO@sterinova.com or by phone at 1 844-329-2939.

 

Regards,

 

                                               

Daniel Abran

Head QA