Recall

Starter-Grower 50-lb bag (Product No. 70009AAA44); Pen Pals Chicken Starter-Grower 25-lb case (Product No. 70009AAABE); MoorMan’s ShowTec Sale Burst w/DF DEN 50-lb. bag (Product No 21256CVWE4); MoorMan's Show-Tec Burst Starter with DFCTC/DEN 50-lb. bag (Product No: 24320AYWE4); ShowTec BB 18 BMD 50-lb. bag (Product No. 18241AGNE4); ShowTec 14.5/6 BMD 50-lb. bag (Product No. 14560AGN); AMPT-A CTC/IGR 50-lb. bag (Product No. 54229XNK); ShowTec Hi Fat 18 BMD 50-lb. bag (Product No. 18007AGN); Seniorglo 50-lb. bag (Product No. 10130AB) and MotivAte 12-15 DEN 50-lb. bag (Product No. 12286CVW). One customer reported chicken deaths related to consumption of the Pen Pals Chicken Starter-Grower 25-lb bags.

The lot number for the Pen Pals Chicken Starter-Grower 25-lb bags involved in this recall is Lot 507650QN. This product may contain elevated levels of calcium and phosphorus, which could lead to leg deformities, trouble standing and walking, and can be fatal to chickens. This product was distributed between Feb. 29, 2024 and March 8, 2024, and could have been purchased through distributors in Iowa and Missouri.

The lot number for the Pen Pals Chicken Starter-Grower 50-lb bags and Pen Pals® Chicken Starter-Grower 25-lb case involved in this recall is Lot 506942QN. These products may contain elevated levels of magnesium, which can cause bone deformities, slow growth rate, watery feces and can be fatal to chickens. These products were distributed between Feb. 28, 2024 and March 14, 2024, and could have been purchased through distributors in Missouri, Ohio, South Carolina, Iowa, California and Oregon.

The lot number for the MoorMan’s ShowTec Sale Burst w/DF DEN 50-lb. bags involved in this recall is Lot 506664QN. This product may contain increased levels of sodium and chloride, which can lead to reduced feed intake, thirst and diarrhea. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in Iowa, Wisconsin and Colorado.

The lot number for the MoorMan’s ShowTec Burst Starter w/DF CTC/DEN 50-lb. bags involved in this recall is Lot 506640QN. This product may also contain increased levels of sodium and chloride. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in Iowa, Wisconsin and Colorado.

The lot number for the ShowTec BB 18 BMD 50-lb. bags involved in this recall is Lot 506939QN. This product may also contain increased levels of sodium and chloride. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in California, Illinois, Arizona, Missouri, and Iowa. The lot number for the ShowTec 14.5/6 BMD 50-lb. bags involved in this recall is Lot 507900QN. This product may contain increased levels of calcium, which could cause reduced feed intake and feed conversion. This product was distributed between March 8, 2024, and March 18, 2024, and could have been purchased through distributors in Iowa.

The lot number for the AMPT-A CTC/IGR 50-lb. bags involved in this recall is Lot 507828QN. This product may contain increased levels of sodium, which could cause loose stools and central nervous system issues. This product was distributed on March 1, 2024, and could have been purchased through distributors in Missouri.

The lot number for the ShowTec Hi Fat 18 BMD 50-lb. bags involved in this recall is Lot 505791QN. This product may contain increased levels of magnesium and calcium, which could cause reduced feed intake and feed conversion. This product was distributed between Jan. 26, 2024, and Feb. 7, 2024, and could have been purchased through distributors in Iowa, Oregon and California.

The lot number for the Seniorglo 50-lb. bags involved in this recall is Lot 505426QN. This product may contain increased levels of calcium, which could cause weight loss and the animal to become weak and listless. This product was distributed between Jan. 24, 2024, and Feb. 1, 2024, and could have been purchased through distributors in Missouri, Illinois, Ohio, Tennessee as well as from ADM locations in Glencoe, Minn., Springfield, Mo. and Dublin, Texas.

The lot number for the MotivAte 12-15 DEN 50-lb. bags involved in this recall is Lot 507330QN. This product may contain increased levels of calcium and phosphorus, which could cause reduced feed intake and feed conversion This product was distributed on Feb. 27, 2024, and March 4, 2024, and could have been purchased from ADM locations in Glencoe, Minn. and Columbus, Neb. After receiving a customer complaint related to swine refusing to eat feed from a single lot of MoorMan’s ShowTec Sale Burst w/DF DEN, ADM immediately investigated and discovered that the company’s animal feed manufacturing facility in Quincy, Illinois, experienced an equipment failure issue that impacted ingredient distribution in the plant.

The company initiated the recall once it was confirmed that these specific lots could contain harmful levels of calcium, phosphorus, magnesium sodium, and/or chloride. ADM has been in direct contact with the customers and distributors involved in this recall, and all product has been removed from retail shelves.

The lot number can be found at the bottom of the label. Customers who have purchased the recalled feed should immediately stop using it and return it to their distributor or directly to ADM Animal Nutrition for a full refund.

Company name: ADM Animal Nutrition
Brand name: Multiple Brand Names
Product recalled: Chicken Feed, Swine Feed, Cattle Feed, Horse Feed
Reason of the recall: Specific lots may contain elevated levels of calcium, phosphorus, magnesium, sodium and/or chloride and may harm chickens, swine, beef cattle and equine.
FDA Recall date: April 01, 2024

Source: www.fda.gov

inside of the vial.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly 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. To date, Eugia US LLC has not received any reports of adverse events related to this recall.

Methocarbamol injection USP 1000 mg/10 mL (100mg/mL), is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is packaged in 10 mL and packed as 25 (vials) X 04 (Printed E-Flute cartons) X 01 (Shipper) with NDC code as 55150-223-10. Eugia US LLC shipped the entire lot to wholesalers nationwide from Jan 12, 2024, through Jan 16, 2024.

The product can be identified by product name on carton and vial label and with lot number 3MC23011 and Exp. Date: Nov 2026 (NDC 55150-223-10) (See enclosed vial label). The product label is as shown in the image below.

Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hospitals, pharmacies, institutions, and doctors with an existing inventory of the recalled product lot should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product lot, notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.

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.

If you are experiencing any harm after using this product 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 attention.

Company name: Eugia US LLC
Brand name: Eugia US LLC
Product recalled: Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)
Reason of the recall: Device & Drug Safety – Presence of Particulate Matter
FDA Recall date: March 28, 2024

Source: www.fda.gov

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

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

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: www.accessdata.fda.gov

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

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: www.jnjmedtech.com
Source: www.fda.gov

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: www.fda.gov

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

on Amazon.com since September 15, 2023. There have been no reports of injury or illness, to date.

The recalled product, which contains yellow oleander instead of tejocote, may induce serious neurologic, gastrointestinal, and cardiovascular adverse health effects. Symptoms may be severe or fatal, including nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac dysrhythmia, and others. Immediate medical attention is advised for consumers experiencing such symptoms.

Product Name: Alipotec King, Alipotec Raiz de TejocoteContainer
Description: Cylindrical bottle with a green top, white body, and contains approximately 30 granules, weighing a total of 0.35oz.
Lot Codes: 238124
Expiration date: 08-2027
Total Distributed: 280 Bottles
Consumer Instructions: Consumers should immediately discontinue use of the product.

In case you experience harm from extraneous materials, 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: Backstage Center
Brand name: Alipotec King
Product recalled: Alipotec Raiz de Tejocote
Reason of the recall: Product contains yellow oleander, a poisonous plant
FDA Recall date: February 23, 2024

Source: www.fda.gov