September 22, 2016
More than 23,000 bottles of pantoprazole sodium delayed-release tablets are being recalled after the discovery of foreign tablets via a complaint, according to the US Food and Drug Administration’s (FDA) Enforcement Report.
The foreign tablet turned out to be a montelukast sodium chewable tablet.
The Class II recall was launched by Aurobindo Pharma USA, and the products were manufactured at the company’s facility in India.
The impacted lot is PSSB16011-A, with an expiration of January 2018 (NDC 65862-0560-90). The products were distributed only in California.
Aurobindo’s recalls have made the news less frequently than a number of other companies. The last time Pharmacy Learning Network reported a recall from this company was in November 2014 when it recalled gabapentin capsules after discovering that some of the capsules were empty.