FDA prohibits use of Ranitidine Injections supplied to Government hospitals in Maha

Source: The Hitavada      Date: 07 Dec 2018 09:59:56


By Rajendra Diwe,

Some black particles were found suspended in the injections when FDA officials collected samples from GMCH in Aurangabad

Following presence of black residual particles in Ranitidine Injection supplied to Government Medical College and Hospital (GMCH) in Aurangabad, Maharashtra Food and Drugs Administration has prohibited use of this allegedly contaminated Ranitidine Injections.

According to Amrut T Nikhade, Joint Commissioner FDA Maharashtra, “The samples of Ranitidine Injection meant for Government supply were found having some black particles suspended in the injection ampoules. The use of this injection has been prohibited in all Government hospitals in State. The samples have been sent for analysis to Government’s Central Drug Testing Laboratory in Mumbai. The analytical reports are expected in 15 days.”
FDA will take action after receiving the analytical reports, he said.

Ranitidine is a very popular antacid drug widely used to treat ulcers of stomach and intestines and prevents its recurrence. According to FDA, “Medical colleges and hospitals in Maharashtra had received 80,000 doses in a consignment and administered 20,000 of them to patients between October 10, 2018 and November 24, 2018 in State.” Only analytical report from Drug Testing Laboratory will confirm whether the injections supplied to the Government Hospitals are ‘not of standard’ or ‘spurious’. FDA as a precaution has prohibited the use of Ranitidine injections in State, Nikhade stated.

All Government Hospitals and Medical Colleges in State are receiving supply of medicines from Haffkine Bio Pharmaceutical Corporation Limited through centralised drug procurement system. The Ranitidine injections have been supplied on October 10, 2018 on the basis of tendering process.

Ranitidine belongs to a class of antacids or anti-ulcer drugs known as H2 blockers. It is widely used in treating certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). Ranitidine is known to decrease the increased acid content produced in stomach. The acidity can also cause symptoms such as cough that doesn’t go away, stomach pain, heartburn, and difficulty in swallowing. Many hospitals including Government or Private Hospitals are using Ranitidine injection as a short term treatment conditions when one cannot take this medication by mouth. This is an intravenous (inside vein) or intramuscular (inside muscle) injection given to patients as directed by physicians. Premixed bags of the injection is given intravenously. The dose and length of treatment depends on medical condition and patient’s response. Also the dose is regulated as per the body weight in children.

FDA has advised patients to know the drug if they are using at home. Medical Practitioners should study the method of preparation and usage instructions from the leaflets provided with the injection ampoules. Medical practitioners should first visually check the product before its use for any suspended particle, discoluration or for any foreign body in the ampoules of injection.