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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 841–860 of 1,000 recalls

Class IITerminated

Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

January 13, 2023 · DrugView details →

Class IITerminated

S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9

Nephron Sc Inc

Short Fill

January 13, 2023 · DrugView details →

Class IITerminated

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4

Nephron Sc Inc

Short Fill

January 13, 2023 · DrugView details →

Class IITerminated

Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01

Accord Healthcare, Inc.

Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

January 12, 2023 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.

Nephron Sc Inc

CGMP Deviations: potential for trace amounts of product carryover.

January 12, 2023 · DrugView details →

Class IITerminated

Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.

Nephron Sc Inc

CGMP Deviations: potential for trace amounts of product carryover.

January 12, 2023 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories

Amerisource Health Services LLC

Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

January 11, 2023 · DrugView details →

Class IITerminated

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

Nephron Sterile Compounding Center LLC

Lack of Assurance of Sterility

January 6, 2023 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.

Ascend Laboratories, LLC

Failed Dissolution Specification

January 5, 2023 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01.

Ascend Laboratories, LLC

Failed Dissolution Specification

January 5, 2023 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.

Ascend Laboratories, LLC

Failed Dissolution Specification

January 5, 2023 · DrugView details →

Class IITerminated

QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Lack of Assurance of Sterility

December 30, 2022 · DrugView details →

Class IITerminated

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Lack of Assurance of Sterility

December 30, 2022 · DrugView details →

Class IITerminated

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Lack of Assurance of Sterility

December 30, 2022 · DrugView details →

Class IITerminated

Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Lack of Assurance of Sterility

December 30, 2022 · DrugView details →

Class IITerminated

QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Lack of Assurance of Sterility

December 30, 2022 · DrugView details →

Class IITerminated

BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Lack of Assurance of Sterility

December 30, 2022 · DrugView details →

Class IITerminated

QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Lack of Assurance of Sterility

December 30, 2022 · DrugView details →

Class IITerminated

Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Lack of Assurance of Sterility

December 30, 2022 · DrugView details →

Class IITerminated

Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Lack of Assurance of Sterility

December 30, 2022 · DrugView details →

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