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Cefdinir

FDA recalls

8 rows

DateCompany and reasonClass
May 7, 2024Lupin Pharmaceuticals Inc.
Defective container: lack of seal integrity.
Class II · Terminated
Apr 23, 2024Lupin Pharmaceuticals Inc.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Terminated
Jul 1, 2020Lupin Pharmaceuticals Inc.
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class II · Terminated
Oct 31, 2019Lupin Pharmaceuticals Inc.
Presence of Foreign substance: identified as a dead ant.
Class III · Terminated
May 22, 2019Lupin Pharmaceuticals Inc.
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Class II · Terminated
Jan 1, 2019Lupin Pharmaceuticals Inc.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Terminated
Mar 26, 2018Lupin Pharmaceuticals Inc.
Superpotent Drug
Class II · Terminated
Feb 25, 2013Teva Pharmaceuticals USA, Inc.
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).