Class I - Dangerous
Failed Stability Specifications
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
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.
Class I - Dangerous
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Hikma Injectables USA
Class I - Dangerous
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
SOMERSET THERAPEUTICS
Class I - Dangerous
Failed Impurities/Degradation Specifications