niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial recall — FDA D-0399-2025
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
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…
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…
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
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…
Potential contamination with patulin.
Potential contamination with foreign objects.
The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.
Glass fragments found in finished product.
The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.
Potential contamination with foreign objects.
Undeclared Milk - During an FDA inspection the firm was notified that milk was not declared on the label.
Product does not declare the allergen, milk, on the label.
The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.
Undeclared allergen: Wheat
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability…
Lack of Assurance of Sterility: Leaking/damaged syringes.
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
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