Gamunex-C 40G Vials Withdrawn
April 08, 2025
On March 21, 2025, Grifols Therapeutics LLC withdrew one additional lot of Gamunex-C® (immune globulin injection [human]
Recall Notices
Sodium Bicarbonate Recalled
March 26, 2025
On March 13, 2025, Exela Pharma Sciences, LLC recalled two lots of 8.4% sodium bicarbonate injection, USP 50mEq/50mL.
Gamunex-C Lot Withdrawn
March 05, 2025
On Feb. 20, 2025, Grifols Therapeutics LLC withdrew one lot Gamunex-C® (immune globulin injection [human], 10% caprylate/chromatography purified) 40G vial to the consumer level for due to an increased rate of reported hypersensitivity reactions with the affected lot.
Fentanyl Transdermal Recalled
February 21, 2025
On Jan. 31, 2025, Alvogen, Inc. issued a recall for one lot to the consumer level for Fentanyl Transdermal System 25 mcg/h transdermal patches.
Additional Lot of Xembify Withdrawn
February 11, 2025
On Jan. 10, 2025, Grifols Therapeutics LLC withdrew one lot to the consumer level for Xembify® (immune globulin subcutaneous, human-klhw) 20% 4G vial due to an increased rate of reported hypersensitivity reactions with the affected lot.
Epinephrine Nasal Solution - FDA Warning
January 22, 2025
On Jan. 16, 2025, the FDA warned healthcare professionals not to use unapproved epinephrine nasal solutions from BPI Labs and Endo
One Lot of Xembify Withdrawn
January 17, 2025
On Jan. 13, 2025, Grifols Therapeutics LLC withdrew one lot to the consumer level for Xembify® (immune globulin subcutaneous, human-klhw) 20% 4G vial
Systane Eye Drops Recalled
December 30, 2024
On Dec. 21, 2024, Alcon Laboratories recalled one lot of Systane® Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count to the consumer level.
Adrenalin Recalled
December 30, 2024
On Dec. 20, 2024, Endo, Inc., the parent company of Par Pharmaceutical, recalled six lots of Adrenalin® Chloride Solution
Clonazepam Orally Disintegrating Tablets Recall
November 22, 2024
On Nov. 19, 2024, Endo Pharmaceuticals, the parent company of Par Pharmaceuticals, notified the FDA of an expansion of its voluntary recall of Clonazepam Orally Disintegrating Tablets
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