Category: Animal & Veterinary

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Drugs
Reason for Announcement:
Excess lead in product
Company Name:
InHE Manufacturing, LLC
Brand Name:
Multiple brand names
Product Description:
Hemp Oil Tinctures

Company Announcement

This recall press release was issued by the firm on 06-23-2020 and is subsequently being posted by FDA at this time only to benefit the public for informational purposes.

Human Consumption (MHR Brands)

Tasty Drops – Berry Tincture, 1oz/300mg

FG003175

Tasty Drops – Berry Tincture, 1oz/500mg

FG003137 FG003174, FG003197, FG0057

Tasty Drops – Berry Tincture, 1oz/1500mg

FG003141, FG003202, FG003296

Tasty Drops – Natural Tincture, 1oz/500mg

FG003138, FG003248

Tasty Drops – Natural Tincture, 1oz/1500mg

FG003142, FG003247

Tasty Drops – Spearmint Tincture, 1oz/300mg

FG003167

Tasty Drops – Spearmint Tincture, 1oz/500mg

FG003139, FG003166, FG003191, FG003225, FG003253, FG003263

Tasty Drops – Spearmint Tincture, 1oz/1000mg

FG003095

Tasty Drops – Spearmint Tincture, 1oz/1500mg

FG003143, FG003180, FG003201, FG003224, FG003262

Tasty Drops – Vanilla Tincture, 1oz/300mg

FG003126

Tasty Drops – Vanilla Tincture, 1oz/500mg

FG003140, FG003182, FG003246

Tasty Drops – Vanilla Tincture, 1oz/1500mg

FG003144, FG003249

Made by Hemp – French Vanilla Tincture, 1oz/1000mg

FG003107

Made by Hemp – Mojito Lime Tincture, 1oz/1000mg

FG003110

Made by Hemp – Strawberry Crème Tincture, 1oz/1000mg

FG003109

Pet Consumption (MHR Brands)

Tasty Drops – Cat Tincture 1oz/200mg

FG003156, FG003325

Tasty Drops – Dog Tincture 1oz/200mg

FG003157, FG003286, FG003324

Purfurred – Dog Tincture, 1oz/200mg

FG003188

Made by Hemp – Cat Tincture, 1oz/200mg

FG003178

Made by Hemp – Dog Tincture, 1oz/200mg

FG003179

Human Consumption (White Label)

A Clean Choice – French Vanilla Tincture, 1oz/1000mg

FG003106

A Clean Choice – Strawberry Creme Tincture, 1oz/1000mg

FG003108

A Clean Choice – Spearmint Tincture, 1oz/500mg

FG003113

BC Hemp Co LLC – Berry Tincture, 1oz/500mg

FG003312

BC Hemp Co LLC – Natural Tincture, 1oz/500mg

FG003171, FG003183, FG003316

BC Hemp Co LLC – Spearmint Tincture, 1oz/500mg

FG003315

BC Hemp Co LLC – Berry Tincture, 1oz/1000mg

FG003164

BC Hemp Co LLC – Natural Tincture, 1oz/1000mg

FG003318

Goodness Gurus – Berry Tincture, 1oz/500mg

FG003236

Goodness Gurus – Spearmint Tincture, 1oz/500mg

FG003234

Goodness Gurus – Spearmint Tincture, 1oz/1000mg

FG003238

Goodness Gurus – Spearmint Tincture, 1oz/1500mg

FG003237

Herbzeedy LLC – Natural Tincture, 1oz/500mg

FG003122, FG003123

Herbzeedy LLC – Natural Tincture, 1oz/1500mg

FG003121

Javan Anti Aging – Spearmint Tincture, 1oz/300mg

FG003283

Pathway to Wellness – Natural Tincture, 1000mg/30ml

FG003151

The Spiffy Piff – Berry Tincture, 1oz/300mg

FG003277

The Spiffy Piff – Spearmint Tincture, 1oz/300mg

FG003276

Recovery ReLeaf – Vanilla Tincture, 1oz/1000mg

FG003133

Acadia Farms – Canadian Maple Tincture, 1oz/300mg

FG003181

Acadia Farms – Spearmint Tincture, 1oz/300mg

FG003177

Pet Consumption (White Label)

Herbal Renewals – Cat Tincture, 1oz/200mg

FG003213

Herbal Renewals – Pet Blend, 1oz/200mg

FG003223, FG003310

Barkley Bistro – Dog Tincture, 1oz/200mg

FG003145

A Clean Choice – Cat Tincture, 1oz/200mg

FG003117

A Clean Choice – Cat Tincture, 500mg/1oz.

FG003118

A Clean Choice – Dog Tincture, 1oz/200mg

FG003116

A Clean Choice – Dog Tincture, 500mg/1oz.

FG003115

BC Hemp Co LLC – Pet Tincture, 1oz/200mg

FG003165

Boost IV Hydration, LLC – Dog Tincture, 1oz/200mg

FG003270

Acadia Farms – Pet Blend, 1oz/200mg

FG003176

How the company learned of this situation: The Company was recently advised by the Florida Department of Health of the presence of elevated heavy metals (lead) in some of its products. In response to this information, the Company undertook an investigation and determined that the issue related to graduated droppers provided by a third-party packaging supplier.

Exposure to lead could present physical signs and symptoms including, pain, paresthesia/muscle weakness, abdominal pain, nausea, vomiting, diarrhea, constipation, poor appetite, weight loss, symptoms associated with encephalitis, metallic taste in the mouth, shock, hemolysis or kidney damage.

In response and in conjunction with the regulatory authorities, the Company:

  1. issued a voluntary nationwide recall of the affected products, providing every customer with replacement products at no cost to the customer; and
  2. retained a replacement third-party packaging supplier for all replacement and future products.
  3. Discontinue use of graduated droppers in the future.

Prior to notifying customers of this recall, MHR Brands had not received any reports of adverse health effects regarding the recalled products. Consumers should contact their physician or healthcare provider if they experience any symptoms that may be related to using the products being recalled. Consumers should observe pets and contact their veterinarian as signs and symptoms of lead exposure in pets may be similar to those in humans. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Livestock Feed
Reason for Announcement:
Elevated levels of copper
Company Name:
Ridley Block Operations
Brand Name:
Ultralyx
Product Description:
12% Protein Sheep feed

Company Announcement

No other products are affected

Ridley Block Operations is voluntarily recalling Ultralyx® 12% Protein Sheep with batch number HB01679401. The product has been found to contain elevated levels of copper. With prolonged consumption, the affected product could potentially have adverse health effects on sheep, including reductions in daily gains, icterus, partially cirrhotic livers and hemoglobin-stained kidneys. Occasionally, death occurs in copper-toxic sheep.

This recall relates only to Ultralyx 12% Protein Sheep with the following batch numbers printed on the package:

PRODUCT NAME Batch/Lot# Item No./Product No. Package Info.
Ultralyx 12% Protein Sheep HB01679401 24419 50# Block

Customers are asked to remove all product matching this batch number from distribution and inventory and discontinue feeding it immediately.

No other batch number or other Ridley Block Operations products are involved in this voluntary recall. Of the batch of twenty blocks included in the recall, two blocks remain in the marketplace. (more…)

 

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Reason for Announcement:
Due to elevated levels of choline chloride
Company Name:
J. M. Smucker Company
Brand Name:
Natural Balance
Product Description:
Ultra Premium Chicken & Liver Paté Formula

Company Announcement

The J. M. Smucker Company today announced a voluntary recall of one lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat food due to health concerns likely associated with elevated levels of choline chloride.

Ingesting impacted product may cause nausea with excessive salivation, constricted pupils and poor vision, diarrhea or vomiting to more severe symptoms including difficulty walking, muscle shaking, tremors, irregular heartbeat, difficulty breathing, possible cardiac or respiratory failure and, in extreme situations, death. Pet parents are encouraged to contact their cat’s veterinarian immediately if their cat is displaying any of these symptoms.

If pet parents have any product matching the following description in their possession, they should stop feeding it to their cats and dispose of the product. This information can be found on the bottom of each can.

Product Name Retail UPC Code Lot Code Best If Used By Date
Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat food
5.5 oz can
2363353227 9217803 08 04 2021

These products are most commonly sold in pet specialty retailers and online throughout the United States and Canada. No other Natural Balance® products are impacted by this recall. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Livestock Feed
Reason for Announcement:
Due to elevated level of Rumensin (monensin)
Company Name:
PGG/HSC Feed Company, LLC, dba CHS Nutrition
Brand Name:
CHS Inc.
Product Description:
Champion Meat Goat Pellets R20, Medicated Feed

Company Announcement

PGG/HSC Feed Company, LLC, dba CHS Nutrition of Hermiston, Oregon, is recalling 510 bags (50 lbs. each) of Champion Meat Goat Pellets R20, Medicated Feed due to elevated level of Rumensin (monensin).

Monensin is an FDA-approved drug for use in certain animal feeds. However, if the feed contains excessive amounts, the feed can cause monensin toxicity in a number of animal species including goats. Goats ingesting excessive levels of monensin in feed are susceptible to injury and death. In goats, signs and symptoms can include bloated stomach, bloody urine, shortness of breath, muscle weakness or cramps, rapid breathing and death. In humans, monensin could affect handlers of highly concentrated products by causing irritation of the skin, eyes, and respiratory tract through direct exposure. People or animals who consume meat or milk from animals exposed to very high levels of monensin are at risk of indirect exposure, which could potentially lead to ingestion toxicity.

 

Champion Meat Goat Pellets R20, Medicated Feed, was distributed to three consignees in Oregon and Washington between April 20, 2020, and April 29, 2020. NW Farm Supply in Hermiston, Oregon and in Prosser, Washington, further sold the recalled product to downstream customers.

The recalled product is pelleted dry feed and bagged in poly bags with the words Payback Champion Feeds printed on the bag. Each bag weighs 50 lbs. The affected lot number 6705 HM928510 04/17/20 and the UPC code 48252 48640 are printed on the tag of each bag.

Customers reported that three goats have died, and three additional goats were ill but have recovered to date. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Livestock Feed
Reason for Announcement:
Elevated Salt Levels
Company Name:
Kent Nutrition Group
Brand Name:
Kent
Product Description:
Home Fresh Starter AMP Crumble

Company Announcement

Kent Nutrition Group (KNG) of Muscatine, Iowa is voluntarily recalling 27- 25 lb.bags of Home Fresh Starter AMP Crumble from a single batch due to elevated salt levels, which can present illness or death to poultry. Kent Nutrition Group has ceased distribution of this lot as FDA and the company continue their investigation.

Potential health risks of elevated salt levels include decreased growth rate, increased thirst, weakness, difficulty walking, difficulty breathing and death. To date, KNG has received three complaints concerning this product, which included illnesses and deaths in broilers age 12-20 weeks. (more…)

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Drugs
Animal Drugs
Reason for Announcement:
Presence of particulates (iron oxide)
Company Name:
ICU Medical Inc.
Brand Name:
ICU Medical Inc.
Product Description:
Lactated Ringer’s Injection, USP

Company Announcement

ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer’s Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint.

Administration of a drug product that contains metal particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. To date, ICU Medical, Inc. has not received reports of adverse events related to this recall. (more…)