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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 901–920 of 1,000 recalls

Class IIOngoing

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 LLC

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

November 14, 2024 · DrugView details →

Class IIOngoing

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 LLC

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

November 14, 2024 · DrugView details →

Class IIOngoing

UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

MXBBB

cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.

November 14, 2024 · DrugView details →

Class IIOngoing

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 LLC

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

November 14, 2024 · DrugView details →

Class IIOngoing

Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3

Brands International Corporation

CGMP Deviations: lack of adequate release testing.

November 13, 2024 · DrugView details →

Class IIOngoing

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).

American Regent, Inc.

Presence of Particulate Matter: Potential for glass delamination from the vials.

November 11, 2024 · DrugView details →

Class IIOngoing

Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).

American Regent, Inc.

Presence of Particulate Matter: Potential for glass delamination from the vials.

November 11, 2024 · DrugView details →

Class IIOngoing

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, LLC

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

November 11, 2024 · DrugView details →

Class IIOngoing

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, LLC

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

November 11, 2024 · DrugView details →

Class IIOngoing

Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01

Safecor Health, LLC

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

November 11, 2024 · DrugView details →

Class IIOngoing

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).

American Regent, Inc.

Presence of Particulate Matter: Potential for glass delamination from the vials.

November 11, 2024 · DrugView details →

Class IIOngoing

Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01

Safecor Health, LLC

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

November 11, 2024 · DrugView details →

Class IIOngoing

Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01

Safecor Health, LLC

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

November 11, 2024 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17

ACCORD HEALTHCARE, INC.

Subpotent drug

November 8, 2024 · DrugView details →

Class IIOngoing

Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

Aurobindo Pharma USA Inc

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

November 7, 2024 · DrugView details →

Class IIOngoing

Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

Aurobindo Pharma USA Inc

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

November 7, 2024 · DrugView details →

Class IIOngoing

Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05

Aurobindo Pharma USA Inc

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

November 7, 2024 · DrugView details →

Class IIOngoing

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.

November 6, 2024 · DrugView details →

Class IIOngoing

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

cGMP Deviations: Out of specification results for micro in hand soap products.

November 6, 2024 · DrugView details →

Class IIOngoing

boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015

Midlab Incorporated

cGMP Deviations: Out of specification results for micro in hand soap products.

November 6, 2024 · DrugView details →

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