Pharma major Dr Reddy’s Laboratories has initiated recalling of total five lots of bottles of Ranitidine Hydrochloride tablets, USP, of 150 mg strength, which is used in gastric problems, from the US market due to microbial contamination of non-sterile products.
The drug was supplied to three different parties with three different brand names.
According to a notification issued by United States Food and Drug Administration, the recalling has been initiated voluntarily by the city-based drug maker and the same was intimated to the drug regulator through a letter on August 2.
When contacted, a Dr Reddy’s spokesperson said it is difficult to quantify number of bottles to be called and the financial impact in negligible.
Ranitidine Hydrochloride is indicated in gastro- oesophageal reflux disease, treatment of peptic ulcers, treatment of benign gastric ulceration, Zollinger-Ellison syndrome and treatment of duodenal ulceration.
According to FDA, the reason for recall was mentioned as “Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.”
While Equate brand (Acid Reducer) was distributed by Wal-Mart Stores Inc, Equaline brand and Wal-Zan brands were distributed by Supervalu Inc and Walgreen Co, the FDA notification said.
The recall has been initiated under Class II, which has been defined as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.