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
Company name: Zydus Pharmaceuticals Inc.
Brand name: Zydus Pharmaceuticals
Product recalled: Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials
Reason of the recall: Due to Crystalization
FDA Recall date: March 25, 2021
Recall details: Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.
Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells.
To date, Zydus Pharmaceuticals (USA) Inc. has not received any reports of adverse events related to this product recall. Acyclovir Sodium Injection, 50 mg/mL is indicated for the treatment of herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection and varicella-zoster (shingles) infections in immunocompromised patients.
The product is packaged in single-dose glass vials and was distributed nationwide in the USA to Cardinal Health, Amerisourcebergen Drug Corporation and Morris & Dickson Company LLC. The affected Acyclovir Sodium Injection, 50 mg/mL lots include the following lot numbers and expiration dates:
- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000155. Expiry Date: Dec 2021. Pack Size: 10x20 mL, Single-Dose Vial pack.
- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000156. Expiry Date: Jan 2022. Pack Size: 10x20 mL, Single-Dose Vial pack.
- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000126. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.
- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000127. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.
Zydus Pharmaceuticals (USA) Inc. has notified its distributors and customers by email and FedEx overnight courier service and is arranging for the return of all recalled Acyclovir Sodium Injection, 50 mg/mL lots. Hospitals that have the product which is being recalled should stop using it immediately and call our recall coordinating center at 1-855-671-5023 [Call: 1-855-671-5023] Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST.
Consumers with questions regarding this recall can contact Zydus Pharmaceuticals (USA) Inc. by phone: 1-877-993-8779 [Call: 1-877-993-8779] or by email: medicalaffairs@zydususa.com Monday – Friday (excluding holidays), 9:00 am to 5:00 pm 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.
Check the full recall details on fda.gov
Source: FDA
Related Reports
Equate and Nature's Bounty Folic Acid 1MG recalled due to exceeding intake limits, Canada
4 days ago
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
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
Par Pharmaceutical Treprostinil Injection - recalled due to Silicone Particulate Matter, USA
6 days ago
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
Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA... See More SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.
Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.
The list below contains the specific product and codes in scope.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode, Product Code: 0845, UDI-DI: 10614559103906.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode, Product Code: 0846, UDI-DI: 10614559104248.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode, Product Code: 0847, UDI-DI: 10614559104842.
- Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode, Product Code: 0848, UDI-DI: 10614559104859.
Customers should review and follow the instructions provided in the December 2023 recall notification (link given below). Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.
Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.
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: Megadyne Medical Products, Inc.
Brand name: Megadyne
Product recalled: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes
Reason for the recall: Limit use to patients aged 12 years or older.
FDA Recall date: February 29, 2024
Recall link of December 2023: jnjmedtech.com
Source: fda.gov See Less
Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits recalled due to potential lack of sterility, USA
2 weeks ago
Avanos Medical, Inc. voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon of the feeding tube. This recall initiated in direct response to... See More the Nurse Assist, LLC voluntary recall of pre-filled syringes and other sterile water products which was promtpted due to concerns about the potential lack of sterility assurance. Avanos has not been directly contacted with any reported adverse events.
This deficiency may lead to non-sterile products, posing a risk of the water coming into contact with a patient’s surgical site. Any open wound exposed to non-sterile products could potentially put the patient at risk of infection. The pre-filled syringe is the only item in the Avanos feeding tube kit affected by the Nurse Assist recall.
As of Feb. 6, 2024, the FDA reported receiving adverse events associated with use of Nurse Assist products and is further evaluating this information.
Upon evaluating the impact of the Nurse Assist recall, Avanos has identified the affected MIC* Gastric – Jejunal Feeding Tube Kit product codes and lot numbers. Customers receiving the listed lots are instructed to remove all affected kits from facilities and requested to take the following actions:
- Continue normal post-op care for any newly placed MIC* GJ tube.
- Report any adverse events involving these products immediately.
- Check all storage facilities and warehouse locations for affected products and quarantine them.
- Destroy all affected lots in inventory.
- Notify other departments or customers of this recall.
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: Avanos Medical, Inc.
Brand name: Avanos Medical
Product recalled: MIC* Gastric-Jejunal Feeding Tube Kits
Reason of the recall: Potential Lack of Sterility Assurance
FDA Recall date: February 27, 2024
Source: fda.gov See Less
Second Brother, Flushing, Queens, NY, USA
1 hour ago
I too received a red box with a very pretty little ring in it. It was correctly addressed to me. It was from Second Brother 156-10 Metcalf Ave Flushing, NY 11365 See Less
Amazonhotsales from Facebook, Inglewood, CA, USA
2 hours ago
Placed an order on Facebook at Amazonhotsales, they said package was delivered, I did not receive anything from them. I got suckered into another SCAM AND FRAUD!!! See Less
I received a random package today. Return address is:
Online Seller
746 S Glasgow av
I'm in sterling VA See Less
On January 7th 2024 I ordered 2 pairs of shoes that looked like I ordered from Hey Dude site and that it was legit, however it was not. They charged my credit card and I have never received the shoes. SCAM, do not order from them. they should be shut down. This was a site on fb that looked legit. See Less
Boil Water Advisory Lifted, Milton, IN, USA
3 hours ago
The system-wide boil water advisory for customers of the Milton Water and Sewer has been lifted effective 8:58 am March 18, 2024.
Source: 953wiki.com
Published: 2024-03-18 See Less
Recent Interesting Reports
I think it's a fraud. I bought the mystery box a month ago and it hasn't come yet. See Less
I ordered a one time teeth whitening & now I keep Receiving 4 Whitening pens are month that I did not order.
I must have ordered a one time whitening system (I don’t remember doing that) But now I’ve gotten two shipments of 4 each extra whitening... See More pens that I did not order. And there is no phone number or way to reach this company to cancel it. I am 73 years old, and do my best to figure this out, but I cannot afford this. Please help! See Less
Unordered Package from Jerry Yasfbara, 9208 Charles Smith Avenue, Rancho Cucamonga, CA, USA
5 days ago
I just received an empty package. No idea what is was. See Less
Didn't order, South Carolina, USA
1 day ago
I received a package I did not order. Where did he get my info from? See Less
Return items, Pocatello, ID, USA
1 week ago
Trying to return items. Phone number disconnected. Items to big. No return address no way to contact seller. Beware See Less
SCAM_ Using AMAZON Name., PYN*ductivs Online
3 weeks ago
These people are scamming people as if it is Amazon merchandise and you are buying it from amazon with pictures. showing that you are buying a pallet of products and you end up getting a envelope mailed to you. junk in the mail with missing cords and... See More all of it is CHINA JUNK> took me for 284.94. They are advertising as if it is AMAZON> See Less
Scam Package from Jane, Cedar Grove, NJ, USA
1 week ago
Package of 3 pairs of women’s cargo pants, 1 white, 2 Kathi No way to return. Can’t find website Not my size. Too small See Less
regulatory authority, Jürgenstorf, Deutschland
3 weeks ago
Seller makes his own return policy and has several shops on Facebook that include this dubiousness. There are the same return conditions, which can be titled “Wish what”. European law does not apply. See Less
Pkg came by USPS did not order. Has Hazmat service transportation surface only. Return to Jerry (001) Yasfbara 9208 Charles Smith Ave,Rancho Cucamonga ca91730.
I am returning. USPS tracking#9261292700545500070020****
Im in Fair Oaks, CA, USA See Less
Scam Alert, Roseville, CA, USA
3 days ago
I received a jar of verti bioretose that I did not order. Received a shipping charge due bill before it was delivered. Didn’t know what it was as I order other things. This is a scam See Less