Class I - Dangerous
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Granules Pharmaceuticals
Class I - Dangerous
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Class I - Dangerous
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class I - Dangerous
Failed Stability Specifications
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Rising Pharma Holding
Class I - Dangerous
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Class I - Dangerous
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
West-Ward Columbus
Class I - Dangerous
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
CGMP Deviations
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21
Amerisource Health Services
Class I - Dangerous
Presence of Foreign Tablets/Capsules
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Rising Pharma Holding
Class I - Dangerous
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class I - Dangerous
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Class I - Dangerous
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Rising Pharma Holding
Class I - Dangerous
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class I - Dangerous
LABELING: LABEL MIX-UP
Class I - Dangerous
Crystallization
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Class I - Dangerous
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.