MANILA, Philippines–A pharmaceutical company has voluntarily recalled a type of antibiotic used for the treatment of susceptible infections, including upper and lower respiratory tract infections, due to the decrease in potency of the product.
In an advisory, the Food and Drug Administration (FDA) said Cathay YSS Distributors Co. has voluntarily recalled batches of Cefaclor (as monohydrate) 50 mg/mL powder for suspension (oral drops) with the brand name Ceclobid because of changes in the product’s physical appearance.
The recall order covers Ceclobid products with registration number DRP-2101 and lot numbers 140350, 140351, 140629, 140630, 141041 and 141042.
The product is manufactured by EL Laboratories located in the Laguna Technopark in Biñan, Laguna.
The use of the recalled product would present safety risks and potential adverse health consequences, the FDA said.
It has instructed distributors, retailers, hospitals and pharmacies or clinics that have the affected lots of the product to discontinue further distribution, sale and use.
“All consumers are likewise advised not to purchase or use the affected products,” the FDA said, adding that all FDA field officers are ordered to monitor the availability of the product batches in the market.–Tina G. Santos