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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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.
Babcock Dairy Chocolate Peanut Butter Ice Cream, Half Gallon, University of Wisconsin-Madison. UPC 12316-01116.
University Of Wisconsin Madison Babcock Hall Dairy Plant
Undeclared eggs and yellow #5.
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.
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.
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
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
cGMP Deviations: Out of specification results for micro in hand soap products.
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
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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
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
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
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
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.