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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 4001–4020 of 17,755 recalls

Class IIOngoing

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.

AMS Packaging Inc

Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

January 28, 2022 · DrugView details →

Class ITerminated

HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59

Esupplementsales, LLC

Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.

January 28, 2022 · DrugView details →

Class IITerminated

Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

FDA Drug Recalls

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ.

HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59

Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69

APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00

RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03

ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01

Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00

Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10

Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09

Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00

SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41

Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01

Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01

Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1

FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10

Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00

Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09

Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41

Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00

Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00