Class I - Dangerous
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Labeling: Label Mix-Up
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Amerisource Health Services
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class I - Dangerous
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class I - Dangerous
Subpotent drug
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class I - Dangerous
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class I - Dangerous
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
Midlab Incorporated
Class I - Dangerous
cGMP Deviations: Out of specification results for micro in hand soap products.
Class I - Dangerous
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I - Dangerous
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Class I - Dangerous
CGMP Deviations: Inconsistency in the water systems.
Class I - Dangerous
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I - Dangerous
Labeling: Not Elsewhere Classified - Wrong NDC number
Class I - Dangerous
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015
Midlab Incorporated
Class I - Dangerous
cGMP Deviations: Out of specification results for micro in hand soap products.
Class I - Dangerous
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I - Dangerous
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I - Dangerous
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.