November 20, 2019DrugsFDA
Apotex Inc. recalls Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane C
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-1
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Ben
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wil
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Novitium Pharma LLC recalls Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
November 20, 2019DrugsFDA
Novitium Pharma LLC recalls Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
November 20, 2019DrugsFDA
Novitium Pharma LLC recalls Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
November 20, 2019DrugsFDA
Novitium Pharma LLC recalls Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
November 20, 2019DrugsFDA
Lannett Company, Inc. recalls Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philade
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
November 20, 2019DrugsFDA
Golden State Medical Supply Inc. recalls GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
November 20, 2019DrugsFDA
Golden State Medical Supply Inc. recalls GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
November 13, 2019DrugsFDA
Green Lumber Holdings, LLC recalls Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296,
Hazard: Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
November 13, 2019DrugsFDA
ICU Medical Inc recalls 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983
Hazard: Presence of Particulate Matter.
November 13, 2019DrugsFDA
ICU Medical Inc recalls LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-795
Hazard: Presence of Particulate Matter.
November 13, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 6818
Hazard: Presence of Foreign substance: identified as a dead ant.
November 13, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Balt
Hazard: Presence of Foreign substance: identified as a dead ant.
November 13, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 11
Hazard: Presence of Foreign substance: identified as a dead ant.
November 13, 2019DrugsFDA
Sato Pharmaceutical Inc. recalls Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by
Hazard: Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c)
Hazard: Lack of Assurance of Sterility
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.
Hazard: Lack of Assurance of Sterility
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx
Hazard: Lack of Assurance of Sterility
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass
Hazard: Lack of Assurance of Sterility
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.
Hazard: Lack of Assurance of Sterility
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.
Hazard: Lack of Assurance of Sterility
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compoundin
Hazard: Lack of Assurance of Sterility
November 13, 2019DrugsFDA
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.
Hazard: Lack of Assurance of Sterility