The Medicines Control Authority of Zimbabwe (MCAZ) would like to inform all licensed premises in possession of any of the pharmacopeial preparations manufactured by R J Pharmaceuticals (Pvt) Ltd listed below that they are the subject of a recall and should immediately be taken off the shelves and quarantined. The products are unregistered medicines and should be manufactured from licensed premises. The products include, but are not limited to the following:

• Benzyl benzoate emulsion
• Calamine lotion
• Wintergreen ointment
• Whitefield's ointment
• Glycerine & Icthamol
• Methylsalicylate liniment
• Coal tar ointment
• Gentian violet paint
  

Anyone in possession of these products is requested to immediately refrain from selling the products and notify MCAZ of the quantities in their possession by writing or emailing to MCAZ.

All licensees and permit holders are reminded that selling unregistered medicines is a contravention of Section 29 (1) (a) of the Medicines and Allied Substances Control Act (Chapter 15:03).

Propoxyphene is an opioid pain reliever used to treat mild to moderate pain. In 19 November 2010, FDA notified healthcare professionals that dextropropoxyphene has been withdrawn from the US market after new data showed that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. For the same reason, in 2011, Healthcare Canada and Paladin Labs Inc announced that the company has decided to voluntarily recall and withdraw dextropropoxyphene (Darvon-N) on the Canadian market and discontinue the sale of the product.

The MCAZ recently gazetted new legislation for regulation of imports and exports of medicines, entitled Medicines and Allied Substances Control (Import and Export of Medicines) Regulations, 2008 (Statutory Instrument 57 of 2008). 

The guidelines for Good Clinical Practice have been updated. You will find the new guidelines on the Downloads page. The file is entitled "Guidelines for GCP 2010 Zimbabwe", it replaces "Zimbabwe Guidelines for good clinical trial practice", which has been removed from this website.