Senna-gen FDA Alerts

Lohxa LLC Issues Voluntary Nationwide Recall of Senna Syrup 8.8mg/5mL Due to Microbial Contamination

January 12, 2022 – Worcester, MA. Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination.

Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing life-threatening inflammation of the heart, could result in infections that could be life-threatening. To date, Lohxa LLC has not received any reports of adverse events related to this recall.

The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-731-24. The affected Senna Syrup 8.8mg/5mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label below. Product was distributed to AvKare (Wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers.

Lohxa LLC is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.

Consumers with questions regarding this recall can contact Lohxa LLC by 800-641-5564 or by email to info@lohxa.com Monday-Friday from 9am-5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling

FDA Publish Date:April 13, 2020 Company Announcement Date:January 18, 2018 -- Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).

Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic, and renal conditions as well as patients who have recently undergone cardiac bypass graft surgery. Patients may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, which include but are not limited to, myocardial infarction, stroke, congestive heart failure, renal toxicity, bleeding, ulceration, or perforation of the stomach or the intestines. The populations most at risk are: children, pregnant women, nursing mothers, and surgical patients. Magno-Humphries Laboratories, Inc., has not received any reports of adverse events related to this recall to date.

Basic Drugs Brand Senna Laxative, 8.6mg Sennosides, tablet is used as a laxative (natural) to relieve constipation and is packaged in 100-count bottles, with an outer neck seal and a child resistant cap, with Lot#352300, EXP: 01/19 printed on the bottom of the bottle. Basic Drugs Brand Senna Laxative tablets were distributed Nationwide in the USA to secondary distributors, retail pharmacies and via the internet.

Magno-Humphries Laboratories, Inc., has notified its distributor by e-mail and is arranging for the return of all recalled products. Consumers, distributors or retailers that have Basic Drugs Brand Senna Laxative Lot#352300 which are being recalled should stop using the product and return it to Magno-Humphries Laboratories, Inc. or their distributor.

Consumers with questions regarding this recall can contact Jane Humphries at Magno-Humphries Laboratories, Inc. by (503) 684-5464, (800) 935-6737 M-F between 9am to 5pm PT or by e-mail at info@magno-humphries.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling

ISSUE: Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).

Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic, and renal conditions as well as patients who recently undergone cardiac bypass graft surgery. Patients may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, which include but are not limited to, myocardial infarction, stroke, congestive heart failure, renal toxicity, bleeding, ulceration, or perforation of the stomach or the intestines. The populations most at risk are: children, pregnant women, nursing mothers, and surgical patients. Magno-Humphries Laboratories, Inc., has not received any reports of adverse events related to this recall to date.

BACKGROUND: Basic Drugs Brand Senna Laxative, 8.6mg Sennosides, tablet is used as a laxative (natural) to relieve constipation and is packaged in 100-count bottles, with an outer neck seal and a child resistant cap, with Lot#352300, EXP: 01/19 printed on the bottom of the bottle. Basic Drugs Brand Senna Laxative tablets were distributed Nationwide in the USA to secondary distributors, retail pharmacies and via the internet.

RECOMMENDATION: Magno-Humphries Laboratories, Inc., has notified its distributor by e-mail and is arranging for the return of all recalled products. Consumers, distributors or retailers that have Basic Drugs Brand Senna Laxative Lot#352300 which are being recalled should stop using the product and return it to Magno-Humphries Laboratories, Inc. or their distributor.

Consumers with questions regarding this recall can contact Magno-Humphries Laboratories, Inc. by (503) 684-5464, (800) 935-6737 [state days of the week] between 9am to 5pm PT or by e-mail at info@magno-humphries.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
   

[01/19/2018 - Press Release - Magno-Humphries Laboratories]