Aidarex Pharmaceuticals LLC

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 III2016-06-15

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

• recall — Class II2016-06-15

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

• recall — Class II2014-10-29

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