Reasons For Pharmaceutical and Medical Devices Recalls: Mislabeling Issues


All pharmaceutical manufacturers needs to meet the challenges posed by new regulations and stronger pharmaceutical packaging guidelines. There is a growing pressure to understand the new rules, and to make sure that every package label is compliant.


Year to date on 2017, 18.1% of the top pharmaceutical recalls were caused by Mislabeling Issues. Other reasons included Failed Specification with 42.5%, Sterility Issue with 17.2% and Current Good Manufacturing Practice Regulations (CGMP) Deviations with 10.9%.  In the Medical Devices Manufacturing industry, Mislabeling Issues accounted for 10.6% of the recalls, while Quality and Sterility Issues accounted for 22% and 29.2% respectively. 54.2% of recalls in Medical Devices were for software or mislabeling – the same top two reasons as Q4 2016. (1)


Pharmaceutical recalls in Q1 2017 were consistent with the previous quarter, dropping just 2% to 81. Recalled units declined 71% to about 7.3 million, a significant drop from Q4 but in line with levels from Q1 to Q3 2016. Only 2% of pharmaceutical recalls were distributed both domestically and internationally, the lowest quarter since at least 2012.


In Medical Devices, although there was a slight decrease, which dropped 9% to 284, it is still higher than seven of the last 10 quarters. Recalled units saw a more dramatic decrease, declining 85% to about 9.3 million – the lowest quarter since Q4 2013. On Q2 2017, 47.3% of recalls were for software or mislabeling – the same top causes as the previous two quarters. (2)


Associated pharmaceutical Mislabeling Issues can include:

  • Torn and Dithered labels
  • Smudged and Distorted labels
  • Wrong content or missing information
  • Quiet Zone violations
  • Low contrast, low resolution barcodes
  • Incorrect reading position

supplies-zipship-image4498-web-72dpi (1)

Additionally, poor label and ribbon quality can result in:

  • More wear and tear on the printhead
  • Poor print quality creates labels that can’t be scanned correctly
  • Time consuming errors and troubleshooting
  • Increased printing process monitoring


These problems may be caused by using the wrong combination of printing supplies materials.  Zebra Certified Supplies provides a 23-point ISO9001:2008 quality approval process for tests print quality, printer wear and tear and application testing on specific media.

– Compliance barcode media should be tested and approved for standardized scannability;
– Printheads should be tested for printing quality and wear and tear resistance, ensuring compliance with readability lifecycle requirements;
– Adhesive strength on labels should meet required specifications and should be approved the appropriate environment: indoor, outdoor, low and high temperatures, abrasion resistance and chemical resistance.


Understanding the primary reasons for failures can save operations valuable time and effort when diagnosing issues. By equipping their operations with optimal tools and conditions to prevent data loss and process failures, allows the company to have a more efficient process and maintain profits.


To learn more about Life Science Manufacturing Labeling Solutions from MultiSystems, contact us today!


*Hablamos Español: MultiSystems cuenta con la selección mas grande y a los mejores precios en etiquetas, cintas térmicas e identificadores para el cumplimiento de regulaciones.

Permita que unos de nuestros especialista en suministros le ayude a seleccionar la etiqueta para su aplicación y presupuesto.



(1) Sterycycle Recall Index Q1 2017.

(2) Sterycycle Recall Index Q1 2017.




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