Medical Center Pharmacy *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle recall — FDA D-1077-2020
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Complete FDA and NHTSA recall records dated in April 2020.
These records include useful source details for the selected month.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Ford Motor Company (Ford) is recalling certain 2020 Ranger and F-150 vehicles equipped with 10-speed automatic transmissions and certain 2020 Expedition vehicles equipped with a "police"…
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation…
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr…
The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included…
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the…
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An…
Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia.…
There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
The printed expiration dates are incorrect.
Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An…
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An…
The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An…
Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia.…
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.