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)
Nostrum Laboratories, Inc. Metformin HCl Extended Release Tablets, USP 750 mg - recalled due to Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day, USA
January 25, 2021 7:00 PM
Company name: Nostrum Laboratories, Inc.
Brand name: Nostrum Laboratories, Inc.
Product recalled: Metformin HCl Extended Release Tablets, USP 750 mg
Reason of the recall: Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day
FDA Recall date: January 25, 2021
Recall details: Kansas City, Missouri,Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2nd 2020. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.
The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) lot is listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) was distributed Nationwide in the USA to wholesalers who further distributed to pharmacies and patients.
- Product Description: Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets)
- NDC: 29033-056-01
- Lot Number: MET200601
- Expiry Dates: 07/2022
Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 or email firstname.lastname@example.org Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.
Check the full recall details on fda.gov
January 27, 2021 9:01 PM
“Company name: Meitheal Pharmaceuticals, Inc.
Brand name: Meitheal Pharmaceuticals, Inc.
Product recalled: Cisatracurium Besylate Injection, USP 10mg per 5mL
Reason of the recall: Mislabeling
FDA Recall date: January 27, 2021
Recall details: Meitheal Pharmaceuticals, Inc. (“Meitheal”), annou... nced today that it is voluntarily recalling one (1) lot of Cisatracurium Besylate Injection, USP 10mg per 5mL to the user level. The decision to recall the product was made after a product complaint revealed that a portion of Lot C11507A of cartons labeled as Cisatracurium Besylate Injection, USP 10mg per 5mL, containing 10-vials per carton, contained 10-vials mis-labeled as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL.
To date, Meitheal has not received reports of any adverse events or identifiable safety concerns attributed to the lot. There is a reasonable probability that a patient who requires cisatracurium for muscle paralysis as part of general anesthesia is administered phenylephrine instead would not receive any skeletal muscle relaxation and could cause a hyperadrenergic state resolution in elevated blood pressure, arrhythmia and cardiac/brain ischemia. If this is not quickly diagnosed and treated, severe illness or death can occur.
There is a reasonable probability that a patient who requires phenylephrine to increase their blood pressure, such as patients with severely low blood pressure, especially resulting from septic shock who is administered cisatracurium instead could result in a fast onset of muscle paralysis and decrease in oxygen. If this is not quickly diagnosed and treated, severe illness or death can occur within minutes. Cisatracurium Besylate Injection is used as a nondepolarizing neuromuscular blocker.
The affected Cisatracurium Besylate Injection lot being recalled is C11507A, EXP. October 2021. The product can be identified as a 5mL vial stoppered with a rubber stopper and sealed with aluminum seal having an Aqua color flip-off seal. Meitheal commenced shipping the product to customers on August 19, 2020 which was distributed to wholesalers nationwide in the USA.
- Cisatracurium Besylate Injection, USP 10mg per 5mL. Lot Number: C11507A*. Expiration Date: October 2021*. NDC Number: 71288-712-06 (unit of sale) |71288-712-05 (unit of use). Distribution Dates: August 19, 2020 – January 04, 2021.
*Note: Mis-labeled product will have this same Lot Number of C11507A and Expiration Date of October 2021 but will be labeled on the vial as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL, NDC 71288-808-77 (unit of use).
Meitheal has notified its distributors and customers in writing to arrange for return of all recalled product. Customers who have purchased the product should not open the carton or use its contents and should immediately quarantine and return the recalled lot of product. Customers who may have further distributed this product should promptly identify their customers and notify them at once of this product recall.
Consumers with questions regarding this recall can contact Meitheal’s Customer Service weekdays 8:00AM to 6:00PM CST at 844-824-8426. 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, as follows.
Check the full recall details on fda.gov
Source: FDA ”
February 3, 2021 1:00 PM
“Company name: Apotex Corp
Brand name: Apotex Corp.
Product recalled: Enoxaparin Sodium Injection, USP
Reason of the recall: Packaging error resulting in incorrect dosage listed
FDA Recall date: February 03, 2021
Recall details: Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin... Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma Limited, Hyderabad, India.
Health Hazard Assessment: Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration to patients. In one recalled batch (batch CS008, strength 100 mg/mL), if a consumer used a 150 mg/mL concentration packaged in a barrel corresponding to a l00 mg/mL concentration, patients could receive 3.75 mg of Enoxaparin, instead of 3 mg of Enoxaparin. In another recalled batch (batch CT003, strength 120 mg/0.8mL), if a consumer used a 100 mg/mL concentration packaged in a barrel corresponding to a 150 mg/mL concentration, patients would receive 2 mg of Enoxaparin rather than 2.5 mg of Enoxaparin. Accidental overdosage following administration of enoxaparin sodium injection may lead to bleeding complications. Alternative, if the dose administered is less than prescribed, the patient may be subject to developing some blood clotting conditions.
Enoxaparin Sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), Treatment of Acute Deep Vein Thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin and Treatment of Acute ST-Segment Elevation Myocardial Infarction.
The affected Enoxaparin Sodium Injection, USP can be identified by NDC numbers stated on carton and label of the product.
Product: Enoxaparin Sodium Injection, USP
Batch #: CS008
Strength: 100 mg/mL
Syringe Barrel Measurement Markings: 100 mg/mL
Pack Size: 10 x 1mL Single Dose Syringes
NDC NumberOn Carton: 60505-0795-4
NDC Number On label: 60505-0795-1
UPC Code on Carton: 360505079544
UPC Code on label: (01)10360505079510
Product: Enoxaparin Sodium Injection, USP
Batch # : CT003
Strength: 120 mg/0.8mL
Syringe Barrel Measurement Markings: 150 mg/ mL
Pack Size: 10 x 0.8 mL Single Dose Syringes
NDC NumberOn Carton: 60505-0796-4
NDC Number On label: 60505-0796-0
UPC Code on Carton: 360505079643
UPC Code on label: (01)10360505079602
The two (2) affected batches of Enoxaparin Sodium Injection, USP were distributed by Apotex nationwide in the USA to Wholesalers and Warehousing Chains. Apotex Corp. is currently notifying its affected direct account Wholesalers and Warehousing Chains, via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.
Check the full recall details on fda.gov
Source: FDA ”
February 28, 2021 4:02 PM
“Order was sent but just a chain. This is misleading to alot of people who they are ripping off. ”
February 27, 2021 2:19 PM
“my experience was wonderful they had every thing on Schudule. They had Buggies to pick you up.and take you back to your car.it was over 500ppl there. It was a huge crowd however I was in and out with in 25 minutes .Every thing was operating smoothly. Va State Fair
Get your Shot! ”
February 27, 2021 1:09 PM
“I saw a battery powered chain saw on fb, and ordered one. When it came it was a chain with two orange handles. I repeatedly e-mailed the company, and they tried to sell me a chain saw. I especially reviewed the ad and it does say "battery Powered" chain saw. The ad is deceiving and I want my mon... ey back. ”
Drugs being brought into the shelter, North Cambridge Senior Center, Massachusetts Avenue, Cambridge, MA, USA
February 27, 2021 9:33 AM
“People are bringing drugs into this shelter so they can do them in the bathroom.they refuse to let anyone in while they do their drugs. since the staff refuse to address this matter, I have no choice but to file a complaint in court. ”
February 26, 2021 4:41 PM
“Ordered a battery operated pruner & was sent a piece of chain with 2 cloth handles, worthless. Want my money back for false advertisement!!! ”
February 26, 2021 7:31 AM
“I had my first Moderna Covid vaccine Wednesday 2/24/21. I am 68 years old, have had a heart attack and have several anaphylactic reactions to several medications so I was a little worried..had no problems except injection site is sore. (Little more then a flu shot)..stay tuned for 2nd report in a mo... nth.. ”
February 26, 2021 6:42 AM
“Arm pain at injection site after a few hours, and then 14 hours after vaccine experienced nausea, malaise, low grade fever for 2 days. ”
February 25, 2021 10:11 PM
“I didn’t have any bad experience about the covid 19 vaccine i was one of the lucky person that didn’t have any side effects just a light headache next day ”
Recent Interesting Reports
February 13, 2021 3:46 PM
“I bit and bought a $30 GT A26 saw and found out after I had ordered it, that it was only a chain. I contacted the company and said I wanted to upgrade to the $60 chainsaw that was on their website and they said no problem & I would get the whole thing. I just received it and it is a completely diff... erent chainsaw and now the saw is not on their website anymore. Wondering how I can get my money back. ”
February 16, 2021 11:55 PM
“The FSA announced the recall of Boots Multivitamins supplements by Boots because they have been incorrectly packed with multivitamins containing iron. This resulted in vitamin K not being present within the supplement and iron incorrectly added to the supplements instead. Iron has not been mentioned... on the label. This means the product is a possible health risk to individuals who may also be consuming iron supplements in addition to these multivitamins.
FSA advises consumers to stop taking the multivitamin supplements. Instead, return it to the Boots store from where it was bought for a full refund. This recall affects multivitamins sold between 12 and 19 January 2021 only.
- Boots Multivitamins (180 tablets). Item code: 80 57 311. Batch code: 1805 and 1806. Best before: end of November 2022.
This product does not contain vitamin K but does contain iron. Excess supplemental iron can result in gastrointestinal effects such as pain, discomfort, constipation or nausea and vomiting.
Check the full recall details on the FSA website food.gov.uk ”
February 15, 2021 1:00 AM
“I ordered 2 chainsaws from an ad on the internet which popped up while playing cards on my phone from a web company called Blackcass.com. I thought that I was ordering rechargable woodcutter/chainsaws, but received two chains instead. They would not refund my money or allow me to return and get a re... fund. They said that I had ordered the chains when I only see a big picture of a chainsaw. Their website is misleading to say the least. I would say I was scammed. They also scam people on their website with another chainsaw they are selling that has the well known brand name of Stihl on the saw. Then they send you an off brand saw made in China. Fraud indeed! ”
February 1, 2021 4:52 PM
“Morning recieved: Arm sore. Headache. Then broke out in welt type hives from my face down to my toes. Had to go to ER for epi pen and steroids. ”
February 15, 2021 4:47 PM
“The cashier is felling sick. Every one got flu in this restaurant. This place infected with COVID 19
I got full sick. All employees are sick and needed fully attention ”
February 21, 2021 9:27 AM
“I received the 2nd covid 19 vaccine shot from Pfizer at the Amazon site February 20th at 1:00 p.m..
I have a mildly sore right shoulder and no other symptoms. ”
February 21, 2021 7:00 PM
“I ordered a battery operated mini chainsaw. They sent me a chain with a strap on each end. After many emails they told me that I did order it. No, I didn’t. 5 shoulders, I wouldn’t have. I looked them up and that is when I started finding the reports. ”
February 19, 2021 5:13 PM
“I choose not to get the injection because as a Big Pharma trained drug rep, realized Pfizer, Moderna, and AZ were only given Emergency’ FDA approval and skipped the animal trials. The jab offers NO immunity nor does it stop transmission; it is therefore NOT a vaccine. It is nothing more than Expe... rimental Biological Agent for a virus with a 99% survival rate (without any intervention. There are much saver therapeutics. He only benefit to the jab is a lessened symptom. The CDC updates the adverse events every Friday. As you can see from their last report, over 900 have already died and over 11,000 have sustained serious injuries.
The risk/return isn’t favorable. It takes about 7 yrs to develop a vaccine. This is way too soon. ”
February 7, 2021 11:58 PM
“The FDA observed the website offers “Corona Destroyer Tea” for sale in the United States in two options, “Prevention” and “Reversal,” and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
Based on FDA review, this product is an unapproved new dr... ug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and d. Some claims on the website and product label establish the intended use of the product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19
For more information click here: fda.gov ”
February 11, 2021 6:25 PM
“I did very well with my first shot of Moderna. I had no reaction except a very sore arm at the injection sight. ”