SCA Pharmaceuticals Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red recall — FDA D-0211-2021
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
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Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Presence of Particulate Matter - found in reserve sample vials at the firm.
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
CGMP Deviations
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
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 Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
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 Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
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 Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
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