The recall of 53,328 bottles of Teva-Amoxicillin FOS 400mg/5ml 50ml bottles was for the USA market and was implemented on June 27 to the retail level, but classified with the US Food and Drug Administration (FDA) last week.
According to a Teva spokesman, the lot was manufactured at the Teva Canada Limited plant located in Markham, Ontario.
“The issue was discovered during evaluation of stability samples by Quality Assurance,” he told in-Pharmatechnologist.com. “The decision was made to recall the product due to an out-of-specification assay result for a single lot discovered during this scheduled stability testing.”
He added the out-of-specification result was “due to an isolated packaging issue and is not indicative of a stability failure.” As such, appropriate actions and measures were implemented to prevent recurrence.
“The supply of this product has not been impacted and Teva continues to supply to the market. Teva continues to strictly follow quality practices in-line with the compliance requirements and industry standards to ensure our products are safe and of the top quality.”
This is not the first recall of the antibiotic amoxicillin Teva has initiated. In June 2013, a voluntary nationwide recall of 758,554 bottles took place due to discolouration of the product. A yellow to brown amoxicillin powder on the inner foil seal of the bottles was discovered, and the recall was expanded to include a further 109,080 bottles made at the Ontario facility.
And earlier this month, the Israeli drug manufacturer withdrew seven lots of the injectable antibiotic amikacin sulfate due to concerns of contamination with glass particulate matter. The product was made at the firm’s Godollo, Budapest facility which was issued with an import alert in May.