March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care On
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 6984
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 25, 2020DrugsFDA
Perrigo Company PLC recalls Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-
Hazard: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
March 18, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wall
Hazard: Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
March 18, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), pac
Hazard: Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
March 18, 2020DrugsFDA
Redline Pharmacy Solutions recalls Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #10
Hazard: Lack Of Processing Controls
March 18, 2020DrugsFDA
Redline Pharmacy Solutions recalls Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 689
Hazard: Lack Of Processing Controls
March 18, 2020DrugsFDA
Redline Pharmacy Solutions recalls Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Hazard: Lack Of Processing Controls
March 18, 2020DrugsFDA
Redline Pharmacy Solutions recalls Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 689
Hazard: Lack Of Processing Controls
March 18, 2020DrugsFDA
Redline Pharmacy Solutions recalls Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hasti
Hazard: Lack Of Processing Controls
March 18, 2020DrugsFDA
Redline Pharmacy Solutions recalls Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive
Hazard: Lack Of Processing Controls
March 18, 2020DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42
Hazard: Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
March 18, 2020DrugsFDA
Precision Dose Inc. recalls Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Do
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
March 18, 2020DrugsFDA
American Health Packaging recalls Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: Ameri
Hazard: CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
March 18, 2020DrugsFDA
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin
Hazard: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
March 18, 2020DrugsFDA
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin
Hazard: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
March 18, 2020DrugsFDA
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin
Hazard: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
March 18, 2020DrugsFDA
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin L
Hazard: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
March 18, 2020DrugsFDA
Mayne Pharma Inc recalls Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-8
Hazard: Product Mix-Up: A foreign tablet was found in bottle.
March 18, 2020DrugsFDA
Sunstar Guangzhou Ltd. recalls Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Hazard: cGMP Deviation
March 11, 2020DrugsFDA
Pfizer Inc. recalls Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer In
Hazard: Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
March 11, 2020DrugsFDA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical recalls Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmac
Hazard: Lack of Assurance of Sterility
March 11, 2020DrugsFDA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical recalls Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx o
Hazard: Lack of Assurance of Sterility
March 11, 2020DrugsFDA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical recalls Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx onl
Hazard: Lack of Assurance of Sterility
March 11, 2020DrugsFDA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical recalls Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use,
Hazard: Lack of Assurance of Sterility