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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