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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 2221–2240 of 17,711 recalls

Class IIOngoing

VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IIOngoing

VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50

Apollo Care, LLC

Lack of Assurance of Sterility

May 2, 2023 · DrugView details →
Class IITerminated

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.

Glenmark Therapeutics, Inc.

Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.

May 1, 2023 · DrugView details →
Class IIOngoing

Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;

RemedyRepack Inc.

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

May 1, 2023 · DrugView details →
Class IIOngoing

Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01

RemedyRepack Inc.

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

May 1, 2023 · DrugView details →
Class IITerminated

LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00

RemedyRepack Inc.

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

May 1, 2023 · DrugView details →
Class IITerminated

vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0406-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7090-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
Class IITerminated

Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

April 28, 2023 · DrugView details →
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