2,090 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.
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Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Presence of a foreign substance.
Cross Contamination with Other Products.
Presence of a foreign substance.
Cross Contamination with Other Products.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
CooperVision recalled 4,140 MyDay Toric contact lenses sold nationwide in the United States. The recall cites an invalid sterilization cycle for one lot. Patients should stop wearing the lenses and consult their eye care providers for guidance.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Ultra Violette Mini Mates SPF 50 kit sold nationwide in the U.S. is recalled. Testing showed SPF results ranging from 4 to 64. The recall is issued by Grace & Fire USA Inc. The public was notified by letter.
One lot manufactured with an invalid sterilization cycle.
One lot manufactured with an invalid sterilization cycle.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.
Labeling includes shelf life that has not been validated.
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