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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7

Ingenus Pharmaceuticals

Class I - Dangerous

Out of specification for related substances (impurities).

Sep 30, 2022 Prescription Drugs Nationwide View Details →

Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.

AuroMedics Pharma

Class I - Dangerous

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.

Sep 26, 2022 Prescription Drugs Nationwide View Details →

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

Fresenius Medical Care Holdings

Class I - Dangerous

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Oct 11, 2022 Prescription Drugs Nationwide View Details →

Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.

Golden State Medical Supply

Class I - Dangerous

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Oct 6, 2022 Prescription Drugs Nationwide View Details →

Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1

Justified Laboratories

Class I - Dangerous

Marketed Without An Approved NDA/ANDA; Unapproved new drug

Sep 9, 2022 Other Drugs View Details →

Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8

Justified Laboratories

Class I - Dangerous

Marketed Without An Approved NDA/ANDA; Unapproved new drug

Sep 9, 2022 Other Drugs View Details →

Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10

AuroMedics Pharma

Class I - Dangerous

Presence of Particulate Matter: Piece of metal found in a vial

Sep 26, 2022 Prescription Drugs Nationwide View Details →

Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9

Salon Technologies International

Class I - Dangerous

Chemical Contamination: product found to contain benzene

Sep 14, 2022 Other Drugs View Details →

Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.

CIPLA

Class I - Dangerous

Lack of Assurance of Sterility: environmental monitoring failure.

Sep 29, 2022 Prescription Drugs Nationwide View Details →

Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5

Salon Technologies International

Class I - Dangerous

GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Sep 14, 2022 Other Drugs View Details →

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

Sep 14, 2022 Prescription Drugs Nationwide View Details →

Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8

Woodbine Products Co

Class I - Dangerous

Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.

Aug 30, 2022 Other Drugs View Details →

Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)

Pfizer

Class I - Dangerous

Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.

Sep 27, 2022 Prescription Drugs View Details →

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Jun 21, 2022 Prescription Drugs Nationwide View Details →

Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A

Viatris

Class I - Dangerous

Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.

Sep 21, 2022 Prescription Drugs Nationwide View Details →

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.

QuVa Pharma

Class I - Dangerous

Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

Sep 20, 2022 Prescription Drugs Nationwide View Details →

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Jun 21, 2022 Prescription Drugs Nationwide View Details →

Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30

Akorn

Class I - Dangerous

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Sep 21, 2022 Prescription Drugs Nationwide View Details →

Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.

Novartis Pharmaceuticals

Class I - Dangerous

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

Sep 16, 2022 Prescription Drugs Nationwide View Details →

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

Leading Pharma

Class I - Dangerous

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

Aug 23, 2022 Prescription Drugs Nationwide View Details →