Skip to main content Skip to search Skip to main navigation

DRA Pakistan: Rapid Alert on Falsified Propylene Glycol

The Drug Regulatory Authority of Pakistan (DRAP) issued a Rapid Alert on 22 August 2024 regarding counterfeit batches of Propylene Glycol. The batches are tagged with Dow Chemical labels, and some are declared to be from 'Dow Europe GmbH, Made in Germany'.

DRAP received the information from Dow Chemical's subsidiary in Singapore and the responsible  WHO's safety unit. The warning refers to three batches, two allegedly from Dow Europe GmbH (Made in Germany) and one from The Dow Chemical Company. The labels are counterfeit and the quality and safety of the material cannot be guaranteed, according to DRAP. DRAP therefore calls on companies not to use these batches to manufacture medicines.

Companies that have used these batches should have their retained samples analysed immediately. If the samples are contaminated, the affected products should be recalled. In addition, raw materials should be screened before use and finished products should be specifically tested for contamination. More detailed information on the affected batches, including photos of the falsified containers, can be found here.

Meanwhile, the contaminated raw materials have been secured, and an investigation has been initiated. This announcement is the latest in a series of warnings from DRAP regarding propylene glycol in Pakistan.


Source:

Drug Regulatory Authority of Pakistan, Recall Alerts

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be Interested in the Following Articles:

What are the quality requirements for pharmaceutical gases?

What are the quality requirements for pharmaceutical gases?

You can view the answer here:
Read more
EMA: Update on the Guideline “Stability Testing for Variations”

EMA: Update on the Guideline “Stability Testing for Variations”

The EMA has updated the guideline on stability testing for variations (Revision 3, applicable from 15 January 2026).
Read more
EU: Proposal for Simplification of Medical Device Rules

EU: Proposal for Simplification of Medical Device Rules

The European Commission has proposed targeted reforms to simplify the Medical Device Regulation (Regulation (EU) 2017/745, MDR) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, IVDR) and to address structural implementation challenges.
Read more
EU: Proposal for a European Biotech Act

EU: Proposal for a European Biotech Act

The European Commission has presented a proposal for a European Biotech Act aimed at strengthening Europe’s biotechnology potential and accelerating the translation of innovation from the laboratory to the market.

Read more
EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

The EMA has published a concept paper outlining a future revision of Annex 3 (Manufacture of Radiopharmaceuticals) of the EU GMP Guidelines. The paper was developed in collaboration with PIC/S and adopted by the GMDP Inspectors Working Group (IWG) at its November meeting.

Read more
EMA: Q&A on QP Certification Without Physical EU Import

EMA: Q&A on QP Certification Without Physical EU Import

The EMA has published a new Q&A addressing QP certification for batches that are neither manufactured within the EU/EEA nor intended for the EU/EEA market, and that are not physically imported into the EU/EEA.

Read more
Previous
Next