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. Inc voluntarily recalled batches of Cefaclor (as monohydrate) 50 mg/mL Powder for Suspension (Oral Drops) with brand name Ceclobid, also due to changes in the product’s physical appearance.
SCREENGRAB from www.fda.gov.ph
Covered by the recall order are Cefaclor (as monohydrate) 50 mg/mL Powder for Suspension (Oral Drops) with brand name Ceclobid with registration number DRP-2101 and lot numbers 140350, 140351, 140629, 140630, 141041 and 141042.
The product is manufactured by EL Laboratories Inc. located in the Laguna Technopark in Biñan, Laguna.
The affected product presents safety risk and potential adverse health consequences, according to the FDA.
The health agency 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 have been ordered to monitor the availability of the product batches in the market.
“Any adverse reaction experienced from the use of the affected product batches should be reported immediately to the FDA,” it added.