Sandoz Recalls
62 recalls on record in the United States
Sandoz Recalls Aprepitant Capsules and Lidocaine and Prilocaine Cream Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
None reported
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Sandoz Recalls Losartan Potassium and Ezetimibe Prescription Drug Bottles Due to Failure to Meet Child-Resistant Closure Requirements
None Reported
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Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements
The firms have received one report of a child ingesting haloperidol from a blister pack.
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Sandoz Inc recalls Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardou
cGMP deviations: Temperature excursion during transportation.
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Sandoz Inc recalls Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx
Temperature Abuse
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Sandoz Inc recalls Cefazolin for Injection, USP, 1 gram per vial, Sterile, For
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
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Sandoz Inc recalls Buffered Penicillin G Potassium for Injection, USP 20,000,00
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
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Sandoz, Inc recalls Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, R
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
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Sandoz Inc recalls Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose
Temperature Abuse; temperature excursion during shipping
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Sandoz, Inc recalls Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
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Sandoz Inc recalls Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalm
Labeling: Incorrect or missing package insert.
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Sandoz Inc recalls Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes O
Labeling: Incorrect or missing package insert.
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Sandoz Inc recalls Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical
Labeling: Incorrect or missing package insert.
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Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules R
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
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Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
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Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules R
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
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Sandoz, Inc recalls Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, U
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.
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Sandoz Inc recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100
Cross Contamination with Other Products
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Sandoz Inc recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100
Cross Contamination with Other Products
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Sandoz Inc recalls Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, R
Cross Contamination with Other Products
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Sandoz Inc recalls Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, R
Cross Contamination with Other Products
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Sandoz Inc recalls Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles,
Cross Contamination with Other Products
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Sandoz Inc recalls Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx
Cross Contamination with Other Products
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Sandoz Incorporated recalls Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 m
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
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Sandoz Inc recalls Ampicillin for Injection, USP, 500 mg per vial, single vial
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
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Sandoz Incorporated recalls Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-coun
Cross Contamination With Other Product: Imipramine
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Sandoz Inc recalls Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/1
Subpotent Drug; Clavulanic Acid
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Sandoz Inc recalls Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 co
Failed Dissolution Specifications
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Sandoz Inc recalls Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 p
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.
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Sandoz Inc recalls Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-co
Subpotent Drug: out of specification results for assay test.
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Showing 30 of 62 recalls. See all →