🍔 Food 💊 Drugs 🏥 Medical Devices
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10 Class II

Reason: Lack of assurance of sterility.

Wells Pharma of Houston LLC 20231122 Completed
Distributed: Philadelphia, Pennsylvania.
View Details
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1 Class III

Reason: Product Mix-up: Incorrect Product Formulation

Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop 20231109 Terminated
Distributed: USA Nationwide
View Details
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30 Class II

Reason: Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Padagis US LLC 20231101 Ongoing
Distributed: Nationwide in the USA
View Details
Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952. Class I

Reason: MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

SUGARMDS LLC 20231108 Ongoing
Distributed: U.S. Nationwide and online websites.
View Details
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86 Class III

Reason: Failed Dissolution Specifications

SUN PHARMACEUTICAL INDUSTRIES INC 20231122 Terminated
Distributed: Nationwide
View Details
Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265 Class I

Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

Botanical Be 20231020 Ongoing
Distributed: USA Nationwide
View Details
Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598 Class I

Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

Botanical Be 20231020 Ongoing
Distributed: USA Nationwide
View Details
Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138 Class I

Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

Botanical Be 20231020 Ongoing
Distributed: USA Nationwide
View Details
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01 Class I

Reason: Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Bayer Healthcare Pharmaceuticals Inc. 20231106 Terminated
Distributed: Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
View Details
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012. Class II

Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Golden State Medical Supply Inc. 20231110 Terminated
Distributed: Nationwide in the USA
View Details
Page 212 of 1,805 | Showing 10 recalls
Data provided by openFDA