Four medicinal products being pulled off the market —  FDA

(Updated 5:40 p.m.) Four products made to cure could cause harm instead, according to the Food and Drug Administration (FDA).   That's why pharmaceutical companies are voluntarily removing from the market pastilles, a cough syrup, a hemorrhoid tablet and a sterile powder for injection, the FDA said in a July 6 report.   An advisory posted on the FDA website Monday night said Novartis Healthcare Philippines is recalling SCT Batch 1201 of its Varemoid Forte 200 mg tablet for hemorrhoids.   FDA officer-in-charge Nicolas Lutero III cited reports that Varemoid Forte may be contaminated with Pseudomonas aeruginosa and Burkholderia cepacia bacteria, placing users with weak immune systems at risk of infection.   The prognosis was based on a report by the US Centers for Disease Control and Prevention.   GMA News Online is still waiting for a comment from Novartis.   Philippine Health authorities advised consumers Tuesday to stop using a batch of Profurex (Cefuroxime Sodium) 750 mg sterile powder for injection (IM/IV) due to possible contamination.   The FDA said the Cathay Drug Co. Inc. is voluntarily recalling the batch with Lot No. P116069 due to "manufacturing deficiencies."   "Reports have it that a broken glass was found inside a vial of the Profurex 750 mg sterile powder for injection (IM/IV)," Lutero said in FDA Advisory 2012-005   Sought for comment, Cathay Drug refused to speak to GMA News Online.   Wrong label  Two other products were being recalled for labeling errors.   Pfizer Consumer Healthcare is voluntarily recalling Robitussin DM which contains Dextromethorphan HBr (15 mg) and Guaifenesin (100 mg) per 5 ml.   "Reports have it that the affected products have discrepancies on both the primary label and carton regarding the dosage instruction," Lutero said in Advisory 2012-006.   The wrong label specified one teaspoonful or 2.5 ml for children 2- to under 6-years-old. The correct dosage is half teaspoonful, he said. Pfizer could not be reached for comment.   Meanwhile GlaxoSmithKline Philippines Inc. voluntarily recalled two batches of Valda Lemon Pastilles manufactured in Malaysia.   "Two batches are affected: Batch 220212M and Batch 220212L, both manufactured 22 February 2012 in Malaysia," Lutero said in the July 6 advisory.   He said the products were wrongly packed with a Valda Menthol tin base instead of a Valda Lemon tin lid.   However in a phone interview with GMA News Online, medical director Dr. Joven Tanchuco of GlaxoSmithKline challenged the FDA advisory.   While the company is aware of the discrepancies in labels of the Valda Lemon Pastilles, they have merely informed the FDA, and have not recalled any of their products, he added.   “What we did was tell the FDA about the mix up but we were very clear there was no safety issue, the products themselves were okay,” according to the GlaxoSmithKline director.   “We did further testing and we were confident that there were no other discrepancies,” Tanchuco said. Products already in the market would remain there, while further distribution will be discontinued, he added.   Lutero advised those who may have bought the products to "discontinue using their use and immediately coordinate" with the companies involved. — VS, GMA News