🍔 Food 💊 Drugs 🏥 Medical Devices
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 Class III

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

Dr. Reddy's Laboratories, Inc. 20220914 Completed
Distributed: USA 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 Class III

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

Woodbine Products Co Inc 20220830 Terminated
Distributed: NC
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) Class II

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

Pfizer Inc. 20220927 Terminated
Distributed: Distributed in the United States and Puerto Rico.
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 Class I

Reason: Chemical Contamination: product found to contain benzene

Salon Technologies International Inc 20220914 Terminated
Distributed: FL and WA only
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 Class II

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

Salon Technologies International Inc 20220914 Terminated
Distributed: FL and WA only
View Details
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45 Class III

Reason: Failed Viscosity specification: Slightly higher OOS results obtained for viscosity

ALMIRALL, LLC 20220916 Terminated
Distributed: Nationwide within the United States
View Details
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031. Class II

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

Akorn, Inc. 20220921 Ongoing
Distributed: USA Nationwide and Puerto Rico
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 Class II

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

Akorn, Inc. 20220921 Ongoing
Distributed: USA Nationwide and Puerto Rico
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 Class III

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

Leading Pharma, LLC 20220823 Terminated
Distributed: Nationwide within the United States
View Details
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86. Class II

Reason: Lack of Assurance of Sterility

CIPLA 20220915 Terminated
Distributed: Nationwide in the USA and Puerto Rico
View Details
Page 344 of 1,805 | Showing 10 recalls
Data provided by openFDA