Aidarex Pharmaceuticals LLC

Overview

Aidarex Pharmaceuticals LLC is a privately-held company specializing in the distribution and marketing of pharmaceutical products. The company focuses on providing cost-effective healthcare solutions to a diverse clientele.

Therapeutic areas

FDA compliance signals

11 FDA enforcement records linked to this company.

  • recall — Class III2018-08-01

    Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

  • recall — Class III2018-08-01

    Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

  • recall — Class III2018-08-01

    Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

  • recall — Class III2018-05-23

    Presence of Foreign Tablets/Capsules

  • recall — Class III2017-11-01

    Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.

  • 4832017-10-20

    Results not used for expiration dates, storage cond.

  • recall — Class III2017-09-20

    Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

  • recall — Class III2016-07-06

    Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.

  • recall — Class II2016-06-15

    Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.

  • recall — Class III2016-06-15

    CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.

  • recall — Class II2014-10-29

    Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg

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