Skip to main content Skip to search Skip to main navigation
News: International

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:

Question of the Week | GMP-Verlag

What are the Benefits and Limitations of Passive Temperature-Controlled Containers for Drug Transport?

Here's the answer:
Read more
Outsourced Activities in the GDP Environment Part II: Contractual Agreements

Outsourced Activities in the GDP Environment Part II: Contractual Agreements

When outsourcing GDP activities, there is a need for concrete delimitation of responsibilities between a client and a contractor. Read more about the goals and the contents of a quality agreement in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).

Read more
FDA: Adjustment of Nitrosamine Limits for Short-Term Use Medicines

FDA: Adjustment of Nitrosamine Limits for Short-Term Use Medicines

The FDA has updated its recommendations on Acceptable Intake (AI) limits for nitrosamine impurities. Under certain conditions, the Agency now accepts a Less-Than-Lifetime (LTL) adjustment of AI limits for medicinal products that are not intended for lifetime use. This also represents an alignment with the LTL concept of ICH M7(R2).
Read more
Swissmedic: SMS Registration Becomes Prerequisite for GMP Certificates

Swissmedic: SMS Registration Becomes Prerequisite for GMP Certificates

As of 15 November 2026, active substances must be registered in the EMA's Substance Management Services (SMS) database before Swissmedic can include them in establishment licences and GMP certificates for active substance manufacturers. The new requirement results from modifications to the EudraGMDP database.
Read more
News: EMA

EMA: New Q&As for Biological Medicinal Products

The EMA has added a new section to its Q&As on biological medicinal products addressing medicinal products containing secretomes or extracellular vesicles (EVs) obtained from human or animal cells.
Read more
News: Europe

EU: Council Adopts the Pharmaceutical Package

On 28 September 2026, the Council of the European Union adopted the EU pharmaceutical package, marking another important step in the legislative process for the comprehensive reform of EU pharmaceutical legislation.
Read more
Previous
Next