Class ICEFAZOLIN2025-07-09
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
Recalling firm: Sandoz Inc
Class IPENICILLIN G POTASSIUM2025-07-09
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
Recalling firm: Sandoz Inc
Class IEnoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes w2021-12-08
Temperature Abuse; temperature excursion during shipping
Recalling firm: Sandoz Inc
Class IISandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Man2019-10-16
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Recalling firm: Sandoz, Inc
Class IISandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Ma2019-10-16
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Recalling firm: Sandoz, Inc
Class IISandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Man2019-10-16
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Recalling firm: Sandoz, Inc
Class IISandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/2018-12-05
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 intak
Recalling firm: Sandoz, Inc
Class IIIsosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Man2018-11-21
Cross Contamination with Other Products
Recalling firm: Sandoz Inc
Class IIIsosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Man2018-11-21
Cross Contamination with Other Products
Recalling firm: Sandoz Inc
Class IIIsosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manu2018-11-21
Cross Contamination with Other Products
Recalling firm: Sandoz Inc
Class IIITriamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-cou2018-04-25
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Recalling firm: Sandoz Incorporated
Class IIPioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottle2017-03-15
Failed Dissolution Specifications
Recalling firm: Sandoz Inc
Class IITransderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per p2017-03-01
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 patc
Recalling firm: Sandoz Inc
Class IINadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Ma2017-01-04
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Recalling firm: Sandoz Incorporated
Class IIL-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk2016-11-23
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Recalling firm: Sandoz Inc
Class IIL-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL2016-11-23
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Recalling firm: Sandoz Inc
Class IITransderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Mu2016-11-16
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Recalling firm: Sandoz Inc
Class IIPhenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 52016-09-28
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Recalling firm: Sandoz Inc
Class IIEphedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (N2016-09-28
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Recalling firm: Sandoz Inc
Class IIIDicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle,2016-06-29
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Recalling firm: Sandoz, Inc
Class IIIDicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle,2016-06-29
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Recalling firm: Sandoz, Inc
Class IIILisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufacture2016-06-22
Labeling: Incorrect or Missing Package Insert
Recalling firm: Sandoz Inc
Class IIICetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 122015-06-10
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Recalling firm: Sandoz, Inc
Class IIIFluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsule2014-12-17
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Recalling firm: Sandoz Incorporated
Class IIIcandesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Man2014-12-10
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 impur
Recalling firm: Sandoz, Inc
Class IIRopinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, 2013-11-13
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 pre
Recalling firm: Sandoz, Inc
Class IIIHydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets 2013-10-16
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Recalling firm: Sandoz Incorporated