Due to cross-contamination with enalapril maleate, Taro is voluntarily recalling one lot of its lamotrigine tablets at the consumer level.
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Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
The UK MHRA has issued a recall of two ranitidine products from Medley Pharma as a precautionary measure due to possible contamination.
Several organisations have developed guidelines that specifically address genotoxic impurities in pharmaceutical products. Here, Dr Sol Bobst and Gowri Sukumar discuss the regulatory landscape, testing requirements and calculation methods for occupational exposure limits.
The EMA has announced that metformin tablets from outside the EU do not contain unacceptable levels of NDMA impurities and EU metformin is not affected.
The FDA has released a statement on the investigations into the presence of nitrosamines in some drugs; highlighting that there are currently no recalls of metformin within the US.
To further its investigation into the cause of the NDMA impurities found in ranitidine and nizatidine, the FDA has asked manufacturers of these products to expand their testing to include all lots of the medication.
Four companies are recalling batches of certain over-the-counter ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.
Most, if not all pharmaceutical companies will have experienced a product, that has been on the market for a long time, to suddenly and unexpectedly trigger a signal for an unknown substance in the quality control (QC) laboratory approval process.
The FDA has announced that Precision Dose Inc is voluntarily recalling five lots of its ranitidine oral solution in the US.
Technetium-99m (99mTc) is a synthetic radioisotope that is used worldwide to produce radiopharmaceuticals that are mainly used for diagnostic purposes in nuclear medicines. The purity of the final radiopharmaceutical (99mTc-R) can be confirmed by applying chromatographic methods. This method is based on different rates of movement of substances in a…
Specific batches of paracetamol tablets are being recalled as some pots have been found to contain discoloured tablets due to fungal contamination.
The FDA has issued a statement on the results from ranitidine medication testing for nitrosamines, saying that they contain no more NDMA than smoked meats.
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