Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
All Recalls
95,114 total recalls in our database
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
Discoloration and Presence of Foreign Substance
Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
Hetero Labs Limited (Unit V)
Failed Tablet/Capsule Specification; complaint of bulging tablet
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10
BAYSHORE PHARMACEUTICALS
CGMP Deviations
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Potential Endotoxin Contamination
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15ΒΏ
Globus Medical
Specific lots of ALTERAΒΏ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable.
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Siemens Medical Solutions USA
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
Potential Endotoxin Contamination
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation.
VITROS XT7600 Integrated System, Product code 6844461
Ortho Clinical Diagnostics
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8ΒΏ
Globus Medical
Specific lots of ALTERAΒΏ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15ΒΏ
Globus Medical
Specific lots of ALTERAΒΏ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.