December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Sanofi-Aventis U.S. LLC recalls Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, C
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
December 11, 2019DrugsFDA
Fagron, Inc recalls LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4
Hazard: Microbial contamination of non-sterile product.
December 4, 2019DrugsFDA
Avantor Performance Materials Inc recalls Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass b
Hazard: Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per
Hazard: Presence of Foreign Substance: Foreign material found inside the vial.
December 4, 2019DrugsFDA
Preferred Pharmaceuticals, Inc recalls Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg:
Hazard: Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodl
Hazard: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
December 4, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 4, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal P
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 4, 2019DrugsFDA
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy recalls Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pha
Hazard: Lack of sterility assurance.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed b
Hazard: Crystallization: Presence of visible particulate matter.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by Au
Hazard: Crystallization: Presence of visible particulate matter.
December 4, 2019DrugsFDA
AuroMedics Pharma LLC recalls Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by Au
Hazard: Crystallization: Presence of visible particulate matter.
November 27, 2019DrugsFDA
X-Gen Pharmaceuticals Inc. recalls Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limit
Hazard: Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
November 27, 2019DrugsFDA
Teva Pharmaceuticals USA, Inc. recalls Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavi
Hazard: Presence of foreign substance: Brown/black particles found during stability testing.
November 27, 2019DrugsFDA
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-
Hazard: Lack of Assurance of Sterility: Product has the potential to leak.
November 27, 2019DrugsFDA
Integrated Health Concepts Inc. dba Conversio Health recalls Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obi
Hazard: Lack of Processing Controls
November 27, 2019DrugsFDA
Integrated Health Concepts Inc. dba Conversio Health recalls Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Hazard: Lack of Processing Controls
November 27, 2019DrugsFDA
Integrated Health Concepts Inc. dba Conversio Health recalls Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obisp
Hazard: Lack of Processing Controls
November 27, 2019DrugsFDA
Integrated Health Concepts Inc. dba Conversio Health recalls Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, San Luis Obispo, CA 934
Hazard: Lack of Processing Controls
November 27, 2019DrugsFDA
Integrated Health Concepts Inc. dba Conversio Health recalls Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only, Shake Well, Conversio Health, Sa
Hazard: Lack of Processing Controls
November 27, 2019DrugsFDA
Integrated Health Concepts Inc. dba Conversio Health recalls Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo
Hazard: Lack of Processing Controls
November 27, 2019DrugsFDA
Integrated Health Concepts Inc. dba Conversio Health recalls Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Hazard: Lack of Processing Controls
November 27, 2019DrugsFDA
Integrated Health Concepts Inc. dba Conversio Health recalls Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Hazard: Lack of Processing Controls
November 27, 2019DrugsFDA
Integrated Health Concepts Inc. dba Conversio Health recalls Budesonide 0.4mg, 3ML Vial, For Inhalation Only, Conversio Health, San Luis Obispo, CA 93401.
Hazard: Lack of Processing Controls