The Maldives Food and Drug Authority (MFDA) has banned the sale and distribution of a recently imported batch of Aciloc (Ranitidine injection) following the discovery of contaminants in the vials. Sources say the defective injections were identified during initial distribution.
In a statement, the MFDA urged the public to swiftly report any occurrences of the RL21311 batch being sold or distributed in the Maldives. The move aims to minimise potential risks to the public by consuming the Ranitidine injection. To facilitate such reports, the authority has informed the public to call their hotline, reachable at 7200321.
In 2020, the U.S. Food and Drug Administration requested manufacturers to withdraw all prescription and over-the-counter ranitidine drugs from the market, citing an investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. The contaminant is identified as human carcinogens, associated with cancers of the stomach, oesophagus, nasopharynx, and bladder. According to the US FDA, the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.
Following the discovery of the contaminated The MFDA says it will implement enhanced monitoring procedures for all imported medicines in the capital. Port authorities will conduct stringent checks to ensure that only safe and high-quality medications are allowed into the country, the authority said.