Class I - Dangerous
Presence of Particulate Matter: Potential for glass delamination from the vials.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
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.
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.
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
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 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, 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 16714-553-01.
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.
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class I - Dangerous
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma 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