Table 4.

Summary of noted labelling inconsistencies for the suspected falsified medicine.

Description	Comment/ observation as compared with genuine package
Primary label information
Product name	● The name was the same.
Active ingredients	● The composition was the same but not in bold like on the genuine label.
Category of distribution	● Stated as prescription medicines while the genuine print had Prescription only Medicine (POM).
Zambia Marketing Authorisation Number	● The printed Marketing Authorisation number (i.e. Visa number) was not consistent with the Zambia Marketing Authorisation coding.
Storage condition	● The storage condition was different.
Expiry date	● The shelf life was different, that is, the suspected falsified product had a shelf life of 18 months compared with the 24 months on the genuine.
Name and manufacturing site address	● Name of the manufacturer was the same but with incomplete manufacturing site address.
Others	● Additional labelling, for example, instructions were provided unlike in the genuine pack. ● The fill volume was less by over 1 mL compared with the original. ● Orientation of text ‘for external use only’ and barcode was changed.
Secondary label information
Product name	● The name was the same
Active ingredients	● The Active Pharmaceutical Ingredient (API) labelled were the same; however, they were written in a different order and smaller font size.
Expiry date	● The shelf life was different, that is, the suspected falsified product had a shelf life of 18 months compared with the 24 months on the genuine.
Storage condition	● The storage condition was different
Name and manufacturing site address	● Name of the manufacturer was the same but with incomplete manufacturing site address.
Zambia Marketing Authorisation Number	● Not printed on the pack but put on the pack using a sticker. The printed Marketing Authorisation number (i.e. Visa number) was not consistent with the Zambia Marketing Authorisation coding.
Colour of packaging	● Slightly different packaging colours shade.
Others	● The two batches of the suspected falsified products were slightly heavier. ● A combination of English and another language was used. The font size for the ‘directions for use’, bar code, and other instructions were different and placed in different parts of the package compared with the genuine package. ● The package had colour lining on the edge of one face, while the original package did not have.