Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case!
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Add Photo/Video
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by
Loading...
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Ruzurgi® 10 mg tablets - recalled due to Yeast, Mold, and Bacterial Contamination, USA

2 years ago

United States

Company name: Jacobus Pharmaceutical Company Inc.
Brand name: Ruzurgi®
Product recalled: Ruzurgi® (amifampridine) 10 mg tablets
Reason of the recall: Exceeds Specification for Total Yeast and Mold Counts
FDA Recall date: September 13, 2021
Recall details: Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results.

Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections.

The product is used as a treatment for LEMS in patients ages 6 to less than 17 and is packaged in 100 count bottles (NDC: 49938-110-01). The affected Ruzurgi® (amifampridine) tablets lots include the following control numbers and expiration dates:
- Control Number 18038, Expiration 03/2023
- Control Number 18039, Expiration 03/2023
- Control Number 18079, Expiration 05/2023

The Control Number is located to the right of the bottle’s front panel below the D2 Barcode. Ruzurgi® (amifampridine) was distributed worldwide to specialty pharmacies and physicians.

Jacobus was informed of this issue by their Canadian partner that was conducting confirmatory full testing on Control Number 18038. Jacobus conducted an expanded investigation which identified Control Numbers 18039 and 18079.

- Control Number 18038 was distributed between 05/25/2021 – 08/26/2021 (Canada only)
- Control Number 18039 was distributed between 06/01/2021 – 08/10/2021
- Control Number 18079 was distributed between 08/10/2021 – 08/30/2021

Jacobus Pharmaceutical Company Inc is notifying its distributors and customers via regular mail and electronic mail and is arranging for the return of all recalled products.

Consumers that have Ruzurgi® (amifampridine) which is being recalled should stop using and return this product. Consumers with questions regarding this recall can contact Jacobus Pharmaceutical Company Inc. by phone at (609)799-8221 ext. 2120, Monday thru Friday from 9:00 AM to 5:00 PM Eastern Standard Time. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration and other health authorities.

Check the full recall details on fda.gov

Source: FDA

304
1 Share


Related Reports

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can... See More result in an over-potent dosing regimen. The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors. The Lots were distributed between 11/09/2023 and 2/20/2024. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL.
- Pack Size: 80 mL, Expiration Date: 09/2025, Lot: 22613003A, NDC No.: 69238-2261-3.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613004A, NDC No.: 69238-2261-7.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613005A, NDC No.: 69238-2261-7.
- Pack Size: 300 mL, Expiration Date: 09/2025, Lot: 22613005B, NDC No.: 69238-2261-5.

Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Amneal Pharmaceuticals, LLC.
Brand name: Amneal
Product recalled: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
Reason of the recall: Super potent due to bottles being overfilled
FDA Recall date: March 27, 2024

Source: fda.gov
See Less


Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). There have been no reports of injury or illness, to date. They were sold in bulk to... See More other distributors and retailers in California and out of state.

These products have the potential to cause severe adverse health effects due to misuse, overuse, interaction with other medications, underlying health conditions, and overall lack of oversight or consultation with medical professionals.

The products were distributed under 11 different brand names and varied in product form and size. A full list is available in the link below. Consumers should immediately discontinue use of the product.

Company name: Pyramid Wholesale
Brand name: Various
Product recalled: Dietary supplements for sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: March 20, 2024

Source: fda.gov
See Less
288


Several brands of folic acid tablets have been recalled in Canada due to concerns that affected lots may exceed the acceptable intake limit for N-nitroso-folic acid. The recall involves multiple brands distributed across the country.

-Affected products
Brand: Compliments FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG,... See More Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHH
Brand: Equate FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115LRJ & 2G3115NHF
Brand: Health One FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NJL
Brand: Nature's Bounty FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2340T8130A
Brand: Pharmasave FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHG
Brand: Sisu FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115M1C

Consumers are advised to consult their healthcare provider if they have any health concerns related to this recall.

Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca
See Less
84


Central Valley Ag Cooperative has voluntarily recalled its GS Hamster/Gerbil + Turmeric food due to a potential Salmonella contamination. The recall affects both animals and humans and is currently ongoing. The recalled product has been distributed in Kansas.

The recalled product is GS Hamster/Gerbil + Turmeric, sold... See More in bulk super sacks. A total of 7,464 pounds of the product, bearing the lot number B0624179808 11399 OXBOW and a best before date of 2/6/2026, have been recalled.

The recall was initiated after an ingredient in the gerbil/hamster feed tested positive for Salmonella.

The issue was discovered during routine testing by the company. The recall was initiated on February 26, 2024.

In case you are experiencing Salmonella symptoms such as diarrhea, abdominal cramps, and fever, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Source: accessdata.fda.gov
See Less


Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product... See More solution. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022. To date, Par has not received any reports of adverse events related to this recall.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs, or brain which can cause stroke and even lead to death.

Treprostinil Injection is formulated for subcutaneous or intravenous infusion. The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require a transition from epoprostenol to reduce the rate of clinical deterioration.

Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. Vials from the affected lot bear the attached label.

Par is providing written notification to wholesale accounts and the hospital location that has received the affected lot and is arranging for the return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue the use and stop distribution immediately.

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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Endo International, Par Pharmaceutical
Brand name: Par Pharmaceutical
Product recalled: Treprostinil 20mg/20mL Injection
Reason for the recall: Potential Presence of Silicone Particulate Matter
FDA Recall date: March 12, 2024

Source: fda.gov
See Less
303


Colorado Springs Utilities reported about 1,199 customers without electricity in downtown Colorado Springs on Thursday afternoon, Mar 28. The outage started at 3:57 p.m. The estimated time for restoration was listed at 7:47 p.m. The cause of the outage was not determined. Power has been already restored... See More to the area.

Outage link: s3.amazonaws.com
Source: csu.org
Published: 2024-03-28
See Less


A precautionary boil water advisory has been issued for customers who get drinking water from the Runnelstown Utility District, located in Perry County. The notice will affect customers on Hinton Loop, Conway Road, and Pumping Station Road.

Source: wdam.com
Published: 2024-03-28 See Less


JXN Water has issued multiple boil water alerts around the city of Jackson. At least 484 connections are impacted. The streets under the boil water alert are as follows: W. Silas Street, S. Gallatin Street, Union Street, Summer Street, Eddy Street, Cameron Street, Nichols Boulevard, Winfield Street,... See More Savanna Street, Creston Avenue, Veld Drive, Fleming Road, Hines Avenue, Gretchen Street, Avalon Road, Belvedere Road, Wellington Road, Robinhood Road, Broadmoor Drive, Churchill Drive, Cedarhurst Drive, Londonderry Drive, E. Northside Drive, Windy Hill Cove, Spring Valley Drive, Springridge Road, Whiting Road, Dixie Drive, Van Winkle Park Drive, John R Lynch Street and President Street.

Source: wapt.com
Published: 2024-03-28
See Less


The Walnut Bayou Water System issued a boil advisory on March 28, 2024, for areas in Tallulah, La., effective immediately. The affected areas are 772 – 2260 Hwy 80 West, 335 Gregory Rd, Butts Dr, 126 Cox Rd, 149 Hilderbrand Rd, Eldorado Plantation Dr, Averett Rd, 317... See More Fred Morgan Rd, 123 Lance Morgan Rd, Quebec Rd, 108 – 377 West Bear Lake Rd, Bedgood Rd.

Source: myarklamiss.com
Published: 2024-03-28
See Less


The Boil Water advisory issued for customers in the city of Cannon Beach has been removed, according to officials.

Source: cannonbeachgazette.com
Published: 2024-03-28 See Less


Recent Interesting Reports

Received a package from Fullfillment House in Tampa. It’s a container of cream that say Subgenix. Extra strength. Not sure what it is or why I received it. No papers in the packaging See Less
523


I am a Senior living in an adult community. I just retrieved my mail and found 2 small pkgs. from SlimFit Fusion. One is Keto +ACV gummies and the other is Forskolin Extract capsules. I don't know what they are for and I did not order them.... See More

Nothing has happened so far other than receiving these two pks that I didnot order. I know this has to be a new scam but I do not know how to proceed.
See Less
20


I recieved a package in the mail through USPS Ground Advantage labeled fullfilment House P.O. Box 5708 Tampa, Fl with a small white canister labeled Verti. It appears to be some sort of metabolism supplement. I did not ever order this and don''t have any See Less
266


Received a package today from FOR RETURN ONLY containing a cheap silver cross and chain that I did not order! How do these people get my name and address? See Less
52


Scam, Yealdeals

2 weeks ago

Ordered a love seat recliner and got a pair of Gucci shades instead of a recliner See Less


I didn't order this Bee Venom from Geathers Fottys 3646 W. Wolcott Ave., Chicago, IL 60609 USA See Less


Bought a Lighter on line from a TV add that said the lighter was completely Electric and runs without any other fuel source. What I received was exactly the opposite. a Butane fueled lighter. with all the instructions in what appears to be Korean (Horizonal letters from... See More left to right) No return instructions only address is on the USPS label.
The Add on TV is way False and misleading.
See Less
1.4K


Received bottle of subgenix Bioribose. I never ordered this? From fulfillment Tampa FL. Was scammed took my ssi money almost my whole check! Help? How do I go about getting my money back? Received in mail on January 8 2024 and 154.00 was take from my account.... See More Its taken me this long to find you and company I am disabled and not good health. I can't believe this happened. I have to find way get my funds refunded. I just returned being able to looking over my account, mail ect. I see i not only one this has happened to See Less
117


Last 30 days