Class I - Dangerous
Lack of Assurance of Sterility
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
Siddha Flower Essences
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class I - Dangerous
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class I - Dangerous
Presence of Particulate Matter
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Class I - Dangerous
Lack of Assurance of Sterility
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Class I - Dangerous
Subpotent
Class I - Dangerous
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Class I - Dangerous
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class I - Dangerous
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class I - Dangerous
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Class I - Dangerous
Subpotent
Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class I - Dangerous
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.