Aidarex Pharmaceuticals recalls
FDA enforcement reports naming Aidarex Pharmaceuticals LLC as the recalling firm.
- Recall reports
- 10
- Class I (serious)
- 0
- Most recent report
- Aug 1, 2018
- Aug 1, 2018Enalapril Maleate, USP 5MG, 90-count bottle, RX onlyDrug · Aidarex Pharmaceuticals LLCOut-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.Class III
- Aug 1, 2018Enalapril Maleate, USP 2Drug · Aidarex Pharmaceuticals LLCOut-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.Class III
- Aug 1, 2018Enalapril Maleate, USP 5MG, 30-count bottle, RX onlyDrug · Aidarex Pharmaceuticals LLCOut-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.Class III
- May 23, 2018Ferrous Sulfate 325 MG tabletDrug · Aidarex Pharmaceuticals LLCPresence of Foreign Tablets/CapsulesClass III
- Nov 1, 2017ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt LtdDrug · Aidarex Pharmaceuticals LLCFailed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.Class III
- Sep 20, 2017Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharm…Drug · Aidarex Pharmaceuticals LLCFailed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability testClass III
- Jul 6, 2016Ciprofloxacin OPTH 0Drug · Aidarex Pharmaceuticals LLCFailed Impurities/Degradation Specifications: Out of specification results for unknown impurity.Class III
- Jun 15, 2016CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged…Drug · Aidarex Pharmaceuticals LLCCGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.Class III
- Jun 15, 2016CHLORHEXIDINE GLUCODrug · Aidarex Pharmaceuticals LLCFailed Impurity/Degradation Specifications: Out of specifications for unknown impurity.Class II
- Oct 29, 2014Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecut…Drug · Aidarex Pharmaceuticals LLCPresence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mgClass II