Drug Regulatory Authority orders recall of nine ‘poisonous’ syrups manufactured by five pharma companies
The syrups include Allerphene, Zevirol, Texcol DM, Texcol EX, Virol, Torax DM, Bronyl and Speczine.
Drug Regulatory Authority of Pakistan (DRAP) has ordered to recall of nine ‘poisonous’ syrups, manufactured by five pharma companies.
The drug regulatory authority has recalled syrups and imported raw material used in them, following the detection of “poisonous impurities.”
According to a document issued by Drap, syrups manufactured by the companies PDH Pharmaceuticals, Raazee Therapeutics, Siza International, and others are contaminated.
The syrups include Allerphene, Zevirol, Texcol DM, Texcol EX, Virol, Torax DM, Bronyl and Speczine.
These syrups were used to treat allergies, throat, cough, itching, vomiting, nausea and hepatitis.
DRAP has declared all 9 syrups substandard, as substandard ethanol was found to be used in the preparation of these syrups,
According to the DRAP alert, Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations, can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal.
Earlier this month, the regulatory authority seized a batch of PG imported from a Thailand-based company after detecting impurities.
DRAP has advised manufacturers of therapeutic goods to follow these instructions:
(i) If any batch was manufactured using the same lot (C815N30R41) of propylene glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.
(ii) All finished products manufactured from any other lot of propylene glycol of Dow Chemical Thailand should be held. These products should be tested for EG/DEG contamination before releasing them into the supply chain.
(iii) Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.
(iv) Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.
(v) Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.
(vi) Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.
