April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls 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
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, Ph
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 3
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cle
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls 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, PharM
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls 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 Sy
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls 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
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMED
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 15, 2020DrugsFDA
PharMEDium Services, LLC recalls ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free Ph
Hazard: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
April 8, 2020DrugsFDA
Akorn Inc recalls Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by:
Hazard: Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
April 8, 2020DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules
Hazard: Defective Container: Recall is due to breaking and shattering of ampules upon opening
April 8, 2020DrugsFDA
Y-O Management LLC, dba Natural Remedy Store recalls Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Anto
Hazard: 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
April 8, 2020DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Mary
Hazard: Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
April 8, 2020DrugsFDA
Medical Center Pharmacy, Inc. recalls *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
April 8, 2020DrugsFDA
Medical Center Pharmacy, Inc. recalls C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, C
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
April 8, 2020DrugsFDA
Medical Center Pharmacy, Inc. recalls *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
April 8, 2020DrugsFDA
Medical Center Pharmacy, Inc. recalls C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311,
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
April 8, 2020DrugsFDA
Medical Center Pharmacy, Inc. recalls C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN
Hazard: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
April 8, 2020DrugsFDA
The Medicine Shoppe Pharmacy recalls Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952
Hazard: Lack of Assurance of Sterility
April 8, 2020DrugsFDA
Par Pharmaceutical Inc. recalls Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.
Hazard: Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
April 1, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packag
Hazard: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
April 1, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil
Hazard: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
April 1, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles ND
Hazard: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
April 1, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
Hazard: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
April 1, 2020DrugsFDA
Glaxosmithkline Consumer Healthcare Holdings recalls Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20
Hazard: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
April 1, 2020DrugsFDA
Jubilant Draximage Inc recalls DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for
Hazard: Failed Stability Specifications
April 1, 2020DrugsFDA
PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Ph
Hazard: SubPotent Drug: Low out-of-specification results for assay testing.
April 1, 2020DrugsFDA
Nostrum Laboratories Inc recalls Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laborator
Hazard: CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
April 1, 2020DrugsFDA
Mylan Pharmaceuticals Inc. recalls Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047
Hazard: Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.