SCA Pharmaceuticals BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL recall — FDA D-1005-2017
Lack of Assurance of Sterility; product has the potential to leak.
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.
10,690 detailed records are currently available in this category.
Lack of Assurance of Sterility; product has the potential to leak.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Lack of Assurance of Sterility; media fill failure at manufacturer
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Lack of Assurance of Sterility; media fill failure at manufacturer
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Lack of Assurance of Sterility; media fill failure at manufacturer
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and…
Lack of Assurance of Sterility: Customer complaints for leaking bags.
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time…
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
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This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.