Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
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
Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670
Midlab Incorporated
Class I - Dangerous
cGMP Deviations: Out of specification results for micro in hand soap products.
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.
Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
Midlab Incorporated
Class I - Dangerous
cGMP Deviations: Out of specification results for micro in hand soap products.
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
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
Midlab Incorporated
Class I - Dangerous
cGMP Deviations: Out of specification results for micro in hand soap products.
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
THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
CGMP violations.
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06
Unexo Life Sciences Private Limited
Class I - Dangerous
cGMP Deviations