Class I - Dangerous
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05
Sun Pharmaceutical Industries
Class I - Dangerous
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
Class I - Dangerous
Lack Of Processing Controls
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
American Health Packaging
Class I - Dangerous
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
Class I - Dangerous
Lack Of Processing Controls
Class I - Dangerous
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
Class I - Dangerous
Lack Of Processing Controls
Class I - Dangerous
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class I - Dangerous
Product Mix-Up: A foreign tablet was found in bottle.
Class I - Dangerous
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
Class I - Dangerous
Lack Of Processing Controls
Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
Class I - Dangerous
Lack Of Processing Controls
Class I - Dangerous
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
Class I - Dangerous
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class I - Dangerous
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Class I - Dangerous
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
Class I - Dangerous
Lack Of Processing Controls
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Sunstar Guangzhou
Class I - Dangerous
cGMP Deviation