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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 6081–6100 of 17,773 recalls

Class IITerminated

succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

March 16, 2020 · DrugView details →

Class IITerminated

Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

March 16, 2020 · DrugView details →

Class IITerminated

fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952

The Medicine Shoppe Pharmacy

Lack of Assurance of Sterility

March 16, 2020 · DrugView details →

Class IITerminated

fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

March 16, 2020 · DrugView details →

Class ITerminated

Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501

Y-O Management LLC, dba Natural Remedy Store

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction

March 16, 2020 · DrugView details →

Class IITerminated

ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

March 16, 2020 · DrugView details →

Class IITerminated

Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

March 16, 2020 · DrugView details →

Class ITerminated

Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.

Dr. Reddy's Laboratories, Inc.

Defective Container: Recall is due to breaking and shattering of ampules upon opening

March 16, 2020 · DrugView details →

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