India-based Wockhardt's U.S. unit has ordered a national recall of 93,393 bottles of its Captopril heart and hypertension drug for being of the wrong thickness. The U.S. FDA also announced recalls of two Japan-made devices.
Wockhardt USA's recall was a Class II covering production failures that could have adverse health consequences.
The agency's weekly recall posting also listed a mammography diagnostic, Aspire HD, made by Fujifilm Medical Systems.
The FDA said the device's manual lacks instructions "for handling some errors even though the system can be recovered from such errors."
Mitsubishi Heavy Industries recalled its MHI-TM2000 Linear Accelerator System because "the operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred."
Wockhardt's recall was its second in a month. In April, it recalled 13 drugs because they were produced at two of its India plants subject to an FDA import ban.
- here's the FDA notice
- and a story from NDTV