Product may be contaminated with Listeria monocytogenes.
All Recalls
92,900 total recalls in our database
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
Our supplier, GKI, did not have milk declared as an allergen on an item we repackage. Therefore our labels did not contain milk
Failed Dissolution Specification
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
Teva Pharmaceuticals USA
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47
Hetero Labs, Ltd. - Unit III
Presence of foreign substance (screw)
Marketed Without an Approved NDA/ANDA
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Failed Dissolution Specifications.
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
Siemens Healthcare Diagnostics
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device.
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix panels. The iMLSb resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. As the product should not be used when quality control (QC) fails, it is unlikely that there would be any impact on patient results, however, if a customer does not perform QC testing and uses the panel, there is a potential to incorrectly treat a Staphylococcus infection with clindamycin based on the iMLSb test result. This issue can be detected 100% of the time when used per package insert instructions with iMLSb positive strain S. aureus BAA-977.
ROSA Surgical Device 2.5.8
Zimmer Biomet
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.