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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 7641–7660 of 17,773 recalls

Class IITerminated

Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30

Direct Rx

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer

April 30, 2019 · DrugView details →

Class ITerminated

Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044

Par Pharmaceutical, Inc.

Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product

April 30, 2019 · DrugView details →

Class IITerminated

Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ

Preferred Pharmaceuticals, Inc

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

April 30, 2019 · DrugView details →

Class IIITerminated

Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017.

Pfizer Inc.

Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.

April 29, 2019 · DrugView details →

Class IITerminated

HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10

Advanced Pharma Inc.

Sub-potency

April 26, 2019 · DrugView details →

Class IITerminated

Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01

Zydus Pharmaceuticals USA Inc

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

April 25, 2019 · DrugView details →

Class IIITerminated

Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6

Advantice Health

Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.

April 25, 2019 · DrugView details →

Class IIITerminated

Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7.

Advantice Health

Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.

April 25, 2019 · DrugView details →

Class IITerminated

Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67

US Worldmeds LLC

Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.

April 25, 2019 · DrugView details →

Class IITerminated

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

Zydus Pharmaceuticals USA Inc

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

April 25, 2019 · DrugView details →

Class IIOngoing

Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

AVKARE Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

April 24, 2019 · DrugView details →

Class IIOngoing

Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

AVKARE Inc.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

April 24, 2019 · DrugView details →

Class IIOngoing

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

Legacy Pharmaceutical Packaging LLC

CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

April 24, 2019 · DrugView details →

Class IITerminated

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.

MAJOR PHARMACEUTICALS

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

April 24, 2019 · DrugView details →

Class ITerminated

Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020

D.B.P. Distribution

Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.

April 23, 2019 · DrugView details →

Class IIITerminated

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25

Akorn Inc

Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.

April 23, 2019 · DrugView details →

Class IITerminated

Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ 07456.

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · DrugView details →

Class IITerminated

Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 North 10th Street, Philadelphia, PA 19123.

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · DrugView details →

Class IITerminated

Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches, 12/800 ML Universal Valve pouches per case, 5031-404, d) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, e) 800 ml pouches, 12 x 800ML. KC Valve pouches per case, 5031-404-KC, f) 800 ml pouches, 12/800 ML Universal Valve pouches per case, 5031-404, g) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, h) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, i) 500 ml pouches, 18/500 ML. KC Valve pouches per case, 5031-404-500, j) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, k) 8 oz. bottles, 24/8 OZ. bottles with pumps per case, 5031-440-03, l) 18 oz. bottles, 16 x 18 OZ. Bottles with Pumps per case, 5031-430-02, m) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, n) 1000 ml pouches, 8/1000ML. Disc Pumps pouches per case, 5031-L1000; Choice Antibacterial Hand Soap, packaged as o) 800 ml/27fl.oz. pouches, 12/800 ml Universal Valve pouches per case, 5031-404UV-CH, Manufactured by Inopak LTD., Ringwood, NJ.

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · DrugView details →

Class IITerminated

INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.

Inopak Ltd

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

April 22, 2019 · DrugView details →

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