cGMP deviations: Temperature excursion during transportation.
Sandoz
Temperature Abuse
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
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
Class I - Dangerous
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Temperature Abuse; temperature excursion during shipping
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Labeling: Incorrect or missing package insert.
Labeling: Incorrect or missing package insert.
Labeling: Incorrect or missing package insert.
Class I - Dangerous
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class I - Dangerous
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class I - Dangerous
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Cross Contamination with Other Products
Cross Contamination with Other Products
Class I - Dangerous
Cross Contamination with Other Products
Class I - Dangerous
Cross Contamination with Other Products
Class I - Dangerous
Cross Contamination with Other Products
Class I - Dangerous
Cross Contamination with Other Products
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Subpotent Drug; Clavulanic Acid
Failed Dissolution Specifications
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
Subpotent Drug: out of specification results for assay test.
Labeling: Missing Label
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Class I - Dangerous
Presence of Foreign Substance: Presence of stainless steel particles.
Class I - Dangerous
Subpotent; Hydrochlorothiazide at the 9 month time point.
Class I - Dangerous
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Class I - Dangerous
Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.