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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 5401–5420 of 17,755 recalls

Class IIOngoing

DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →
Class IIOngoing

NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →
Class IIOngoing

IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →
Class IIOngoing

PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →
Class IIITerminated

Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05

US Compounding Inc

Labelling: Missing label.

November 25, 2020 · DrugView details →
Class ITerminated

Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01

Torrent Pharma Inc

Failed Dissolution Specifications

November 25, 2020 · DrugView details →
Class IITerminated

CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01

Simex Logistics SA de CV

Subpotent drug

November 25, 2020 · DrugView details →
Class IITerminated

+Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406 Dallas, Texas 75204 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente. Celaya, Guanajuato, Mexico.

Simex Logistics SA de CV

Subpotent drug

November 25, 2020 · DrugView details →
Class IITerminated

Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC. 1130 Aba St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico, Barcode: 7 05333 5897

Simex Logistics SA de CV

Subpotent drug

November 25, 2020 · DrugView details →
Class IITerminated

Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC 1130 Ada St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fracc. El Puente C.P. 38040 Celaya, Guanajuato, Mexico. smxcontact@simex-logistics.com Barcode: 6 18149 21988 9

Simex Logistics SA de CV

Subpotent drug

November 25, 2020 · DrugView details →
Class IITerminated

UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distributed By UVT World Newport Beach, CA 92660 www.uvt.world Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico Barcode: 7 00306 88677 2

Simex Logistics SA de CV

Subpotent drug

November 25, 2020 · DrugView details →
Class IITerminated

Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.

Ascend Laboratories LLC

Failed Dissolution Specifications; Out of Specification (low) results were obtained.

November 24, 2020 · DrugView details →
Class IITerminated

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054

Ascend Laboratories LLC

Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.

November 23, 2020 · DrugView details →
Class IITerminated

HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

Complete Pharmacy and Medical Solutions, LLC.

CGMP deviations: Lack of potency testing.

November 20, 2020 · DrugView details →
Class IIITerminated

Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90

Novocol Pharmaceutical of Canada, Inc.

Labeling: Label mix-up

November 20, 2020 · DrugView details →
Class IITerminated

HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

Complete Pharmacy and Medical Solutions, LLC.

CGMP deviations: Lack of potency testing.

November 20, 2020 · DrugView details →
Class IITerminated

HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

Complete Pharmacy and Medical Solutions, LLC.

CGMP deviations: Lack of potency testing.

November 20, 2020 · DrugView details →
Class IIITerminated

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

SCA Pharmaceuticals

Subpotency: Out-of-specification stability test result for low potency was obtained.

November 20, 2020 · DrugView details →
Class IITerminated

HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035

Complete Pharmacy and Medical Solutions, LLC.

CGMP deviations: Lack of potency testing.

November 20, 2020 · DrugView details →
Class IITerminated

CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1

US Pharmaceuticals Inc.

Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.

November 19, 2020 · DrugView details →
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