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

Lupin Quinapril tablets - recalled due to nitrosamine impurity, USA

1 year ago

United States

Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue. Lupin discontinued the marketing of Quinapril tablets in September 2022. It was distributed nationwide in the US to wholesalers, drug chains, mail-order pharmacies, and supermarkets.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Quinapril Tablets USP 20mg, and 40mg is packaged in 90 count bottles. The recalled lots are included in the table below:

Product: Quinapril Tablets USP, 20mg
Lot No: G102929
Expiry: 04/2023
NDC: 68180-558-09 (90’s)
UPC: 368180558095
Distribution Dates: 03/15/2021 – 09/01/2022

Product: Quinapril Tablets USP, 40mg
Lot No: G100534, G203071, G100533
Expiry: 12/2022, 12/2022, 03/2024
NDC: 68180-554-09 (90’s)
UPC: 368180554097
Distribution Dates: 03/15/2021 – 09/01/2022

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.

Patients taking, Quinapril Tablets USP, 20mg, and 40mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have Quinapril Tablets USP, 20mg, and 40mg that are being recalled should discontinue distribution of the recalled product lots immediately.

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

Company name: Lupin Pharmaceuticals Inc.
Brand name: Lupin
Product recalled: Quinapril 20 and 40 mg tablets
Reason of the recall: Presence of nitrosamine impurity, N-Nitroso-Quinapril
FDA Recall date: December 21, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-four-lots-quinapril-tablets-due

303


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: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution
See Less
303


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: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pyramid-wholesale-issues-recall-various-brands-products-sold-dietary-supplements-sexual-enhancement
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/en/alert-recall/folic-acid-1mg-affected-lots-exceed-or-may-exceed-acceptable-intake-limit-n-nitroso
See Less
84


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: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-pharmaceutical-issues-voluntary-nationwide-recall-one-lot-treprostinil-injection-due-potential
See Less
303


Brassica Pharma Pvt. Ltd. is voluntarily recalling the Eye Ointment products listed below with expiration dates ranging from February 2024 to September 2025. The products are being recalled due to a lack of sterility assurance. These products were distributed nationwide to wholesalers, retailers, and via the product... See More distributors, Walmart, CVS, and AACE Pharmaceuticals Inc. To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.

For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.

The affected products are:
- Product Name: Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols), Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: Equate, NDC: 79903-026-35, UPC Code: 681131395298.
- Product Name: Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil), Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: Equate, NDC: 79903-028-35, UPC Code: 681131395304.
- Product Name: CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil, Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: CVS Health, NDC: 76168-707-35, UPC Code: 050428634141.
- Product Name: Lubricant PM Ointment, Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: AACE Pharmaceuticals, NDC: 71406-124-35, UPC Code: 371406124356.
For Lot number and expiry dates, you can visit the link below.

Brassica Pharma Pvt. Ltd. Is notifying its distributors AACE Pharmaceuticals Inc and its retailers Walmart and CVS. These distributors shall be further notifying the wholesalers and retailers via mail of this recall and arranging for return of all impacted products listed above. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled Eye Ointment and may return any of the above listed products to the place of purchase.

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: Brassica Pharma Pvt. Ltd.
Brand name: Multiple brands
Product recalled: Eye ointment products
Reason of the recall: Due to Potential Lack of Sterility Assurance.
FDA Recall date: February 26, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/brassica-pharma-pvt-ltd-issues-voluntary-nationwide-recall-equate-lubricant-eye-ointment-equate-stye
See Less
303


On Thursday 28th, SDG&E reported another outage affecting almost 8,000 customers in the neighborhoods of Nestor, San Ysidro and Otay Mesa. The initial restoration time was listed as 2:30 p.m. At 1:20 p.m., all power in these areas was reported to be back on.

Outage link: www.sdge.com/residential/-service/outage-center/outage-map... See More
Source: www.yahoo.com/news/thousands-sdg-e-customers-left-180934562.html
Published: 2024-03-28
See Less


Hundreds of Duquesne Light customers are without power this morning after a car slammed into a pole in Center Township, Beaver County overnight. Duquesne Light’s outage website says that nearly 600 customers across Center Township and Hopewell Township are without power this morning Friday 29th.

Outage link:... See More www.duquesnelight.com/outages-safety/current-outages
Source: www.yahoo.com/news/hundreds-without-power-car-crashes-103229253.html
Published: 2024-03-29
See Less


The Town of Odon advises Oak Street from Main to Race Streets will have water shut off Friday 29th for 4-6 hours during the day. Anyone affected will be on a boil order until further notice.

Source: www.wwbl.com/2024/03/28/odon-water-shut-off-advisory/
Published: 2024-03-28 See Less


I ordered a cross hand made out of recycled horseshoes. I received plastic horseshoes that I have to put together.

www.originaley. com See Less


Recent Interesting Reports

Found what we thought was the Dr.Ozz Keto +ACV gummies & they were supposed to be $39 so we ordered. Immediately we got a message from our bank asking if we did that purchase for $198. We text back no & the bank blocked our card but... See More after pending uts too late. They also told us that person tried to run it 2 more times with no luck because we had already blocked the card. A couple days later we received a package with 5 little jars of gummies but it definitely isn't what we ordered, looks nothing like them. I'm almost positive it's a scam See Less


I just received a package from this company that I did not order.

Im in Los Ángeles, CA, USA See Less
522


I received a package containing a pair of sunglasses that I didn’t order from: Heather’s Motty
2207 Summit ave. Union City NJ 07087 See Less
174


Verti, Ohio, USA

1 week ago

I didn’t order this product. It came in the mail and I was charged $55 and $99 to my bank account. See Less
187


My husband received this package he did not order and his acct was charged twice. It came in white bubble wrap bag. Usps ground fullfillment house po box 5708 Tampa FL 33675 See Less
2


I received manila envelope from Fulfillment Center in Tampa, FL with sealed jar of Verti Bioribose in it. I did not order this product. See Less
278


Last 30 days