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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 181–200 of 438 recalls

Class IICompleted

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Glenmark Pharmaceuticals Inc., USA

cGMP deviations

April 25, 2022 · DrugView details →

Class IICompleted

Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80

Cardinal Health Inc.

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions

April 5, 2022 · DrugView details →

Class ICompleted

Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59

Cardinal Health Inc.

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

April 5, 2022 · DrugView details →

Class IICompleted

Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80

Cardinal Health Inc.

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

April 5, 2022 · DrugView details →

Class ICompleted

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products

March 24, 2022 · DrugView details →

Class ICompleted

MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Plastikon Healthcare LLC

Microbial Contamination of Non-Sterile Products

March 24, 2022 · DrugView details →

Class IICompleted

Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.

Plastikon Healthcare LLC

CGMP Deviations: Failure to properly investigate failed microbial testing.

March 24, 2022 · DrugView details →

Class IICompleted

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.

Plastikon Healthcare LLC

CGMP Deviations: Failure to properly investigate failed microbial testing.

March 24, 2022 · DrugView details →

Class IICompleted

MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Plastikon Healthcare LLC

CGMP Deviations: Failure to properly investigate failed microbial testing.

March 24, 2022 · DrugView details →

Class ICompleted

SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.

Fagron, Inc

Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.

March 4, 2022 · DrugView details →

Class ICompleted

AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2

American Screening LLC

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

November 19, 2021 · DrugView details →

Class ICompleted

Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64

Sandoz Inc

Temperature Abuse; temperature excursion during shipping

November 17, 2021 · DrugView details →

Class ICompleted

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets

October 12, 2021 · DrugView details →

Class IICompleted

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16

Morton Grove Pharmaceuticals, Inc.

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

September 3, 2021 · DrugView details →

Class IICompleted

Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16

Morton Grove Pharmaceuticals, Inc.

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

September 3, 2021 · DrugView details →

Class IICompleted

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16

Morton Grove Pharmaceuticals, Inc.

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

September 3, 2021 · DrugView details →

Class ICompleted

X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2

Phe Inc

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

August 18, 2021 · DrugView details →

Class IICompleted

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Innoveix Pharmaceuticals Inc

Lack of Assurance of Sterility

July 9, 2021 · DrugView details →

Class IICompleted

Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

Innoveix Pharmaceuticals Inc

Lack of Assurance of Sterility

July 9, 2021 · DrugView details →

Class IICompleted

BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10

Oxford Pharmaceuticals, LLC

Presence of Foreign Tablets/Capsules

May 5, 2021 · DrugView details →

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