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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 981–1000 of 17,683 recalls

Class IIOngoing

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Direct Rx

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

January 31, 2025 · DrugView details →

Class IICompleted

fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

Fagron Compounding Services

Lack of Assurance of Sterility

January 31, 2025 · DrugView details →

Class IOngoing

Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47.

Alvogen, Inc

Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

January 31, 2025 · DrugView details →

Class IIOngoing

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed Dissolution Specifications.

January 30, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

Class IIOngoing

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

January 29, 2025 · DrugView details →

SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1

Ascent Consumer Products Inc.

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

January 28, 2025 · DrugView details →

SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7

Ascent Consumer Products Inc.

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

January 28, 2025 · DrugView details →

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