Sandoz GmbH

50 FDA enforcement records linked to this company.

• recall — Class III2026-06-24

  Labeling: Incorrect or Missing Lot and/or Exp Date

• recall — Class II2025-09-24

  cGMP deviations: Temperature excursion during transportation.

• recall — Class II2025-09-17

  Temperature Abuse

• recall — Class I2025-07-09

  Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit

• recall — Class I2025-07-09

  Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

• recall — Class II2022-04-13

  CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

• recall — Class I2021-12-08

  Temperature Abuse; temperature excursion during shipping

• recall — Class II2020-05-13

  Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins

• recall — Class III2019-11-06

  Labeling: Incorrect or missing package insert.

• recall — Class III2019-11-06

  Labeling: Incorrect or missing package insert.

• recall — Class III2019-11-06

  Labeling: Incorrect or missing package insert.

• recall — Class II2019-10-16

  CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

• recall — Class II2019-10-16

  CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

• recall — Class II2019-10-16

  CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

• 4832019-04-16

  Investigations of discrepancies, failures