🍎 Food Class I - Dangerous
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
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95,075 total recalls in our database
🍎 Food Class I - Dangerous
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
🍎 Food Class I - Dangerous
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
After an investigation, the firm discovered that a sifter used in the production of the Dextrose for each product was damaged and introduced metal fragments in the products.
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Amerisource Health Services
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Midlab Incorporated
💊 Drugs Class I - Dangerous
cGMP Deviations: Out of specification results for micro in hand soap products.
💊 Drugs Class I - Dangerous
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, 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 16714-554-01.
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
💊 Drugs Class I - Dangerous
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
💊 Drugs 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
💊 Drugs 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
💊 Drugs Class I - Dangerous
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: Potential for glass delamination from the vials.
💊 Drugs 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
💊 Drugs Class I - Dangerous
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: Potential for glass delamination from the vials.
💊 Drugs 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
💊 Drugs Class I - Dangerous
cGMP Deviations: Out of specification results for micro in hand soap products.
💊 Drugs Class I - Dangerous
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
💊 Drugs Class I - Dangerous
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.