Aurobindo Pharma Limited

50 FDA enforcement records linked to this company.

• recall — Class II2025-06-25

  cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

• recall — Class II2024-12-25

  CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

• recall — Class II2024-12-11

  cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

• recall — Class II2024-12-11

  cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

• recall — Class II2024-12-11

  cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

• recall — Class I2024-08-28

  Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

• 4832024-05-15

  Notify FDA and immediate trading partners of illegitimate product

• recall — Class II2024-05-15

  Discoloration: Dotted and yellow spots on tablets

• 4832024-05-15

  Systems in place to comply with verification requirements

• recall — Class II2024-05-15

  Discoloration: Dotted and yellow spots on tablets

• 4832023-09-29

  Control procedures to monitor and validate performance

• recall — Class II2023-09-27

  Failed dissolution specifications - results obtained were below spec average.

• recall — Class II2023-08-30

  cGMP deviations: Batch was released prior to approval.

• recall — Class II2023-08-30

  cGMP deviations: Batch was released prior to approval.

• 4832023-07-21

  Written procedures not established/followed