Class I - Dangerous
Labeling: Not Elsewhere Classified - Wrong NDC number
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Prescription Drugs
💊 Drugs • 12,141 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
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
Class I - Dangerous
Labeling: Label Mix-Up
Class I - Dangerous
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class I - Dangerous
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Tablet/Capsule Specifications
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
Safecor Health
Class I - Dangerous
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
Safecor Health
Class I - Dangerous
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.