G-SUPRESS DX pediatric drops- recalled due to Incorrect Packaging, Puerto Rico

2 weeks ago

Puerto Rico

Novis PR LLC is voluntarily recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops to the consumer level. Some cartons of the product have been found to contain incorrect product inside. Incorrect product inside is an anesthetic/analgesic and not a brand of Novis PR LLC. Lot D20911 was distributed among pharmacies in Puerto Rico. To date, Novis PR LLC has not receive d any reports of adverse events or injuries related to this recall.

Anesthetic/Analgesic product contains 60% ethyl alcohol and 5% benzocaine. There is a probability of serious adverse events with a product containing alcohol including alcohol toxicity. Infants and young children are prone to profound hypoglycemia coma, and hypothermia from ingesting relatively small amounts of ethanol, and deaths have been reported. Furthermore, the product contains benzocaine but does not include a Warning for methemoglobinemia which is a condition in which too little oxygen is delivered to your cells that can be life-threatening.

G-Supress DX Pediatric Drops is a cough suppressant, expectorant and nasal decongestant used for the temporarily relief of the common cold symptoms, supplied in 1 oz. bottles packaged in a carton box. Oral anesthetic/analgesic liquid used for temporary relief for the mouth and gums supplied in 0.5 fl. oz. (15 mL) bottles.

Novis PR LLC is notifying its distributors and customers by email and telephone calls and arranging return of recalled lot.  Consumers/distributors/retailers that have affected lot should stop using and return to place of purchase. 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. Complete and submit the report Online

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: NOVIS PR LLC
Brand name: G-SUPRESS DX
Product recalled: Cough Suppressant, expectorant, nasal decongestant pediatric drops
Reason of the recall: Device & Drug Safety/Mislabeling
FDA Recall date: May 19, 2023

Source: fda.gov

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BearCare, Inc. is initiating a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) due to reports of injuries, including skin burns, by users. The Walnut Thermometer is an over-the-counter rechargeable device intended for continuous chest temperature monitoring of children ages 0-6 years which can... See More be identified by its silicone exterior resembling a cartoon penguin. The product under recall was sold and distributed from December 2022 to April 2023 through Amazon.com, Walmart.com, and www.walnutcares.com.

The recalled product is:
- Walnut Wearable Smart Thermometer, Lot Number: 20221115W002, Model Number: WT20, Distribution Dates: December 2022 and later.

Components are shown in the image below (1) thermometer unit; (2) base station; (3) adhesive strip; (4) user manual; (5) charging cable.

How to recognize the device may fail: users may identify a failing device if the user observes any substance leaking from the device’s exterior, any corrosion near the smart sensor on the back of the device, diminished battery life, or connectivity issues with the Walnut App. In addition, a sensation of warming or heat at or near the site or redness and irritation on the skin are also signs of that a device is failing.

Consumers are advised to immediately stop using the product. Caution should be taken if there is evidence of moisture or leakage since this may pose a risk of chemical burns to users as well as caretakers or others handling the product. Given the vulnerable population of neonates and infants, other areas of the body should be checked, including the mouth and eyes due to possible transfer of corrosive fluids that may cause chemical burns or toxicity if swallowed. Seek medical care if you or your child were exposed to moisture coming from the device or experience any symptoms related to this device failure.

BearCare is voluntarily recalling this product after receiving consumer complaints of minor to severe skin burns and skin irritation in children that used the product made BearCare aware of an issue. BearCare prioritizes consumer safety and is thoroughly evaluating these complaints. Due to the potential for injury, the Walnut Thermometer consumers are advised to immediately stop using the product.

BearCare is asking consumers to return the product to obtain a full refund of the purchase price. The address return address is:
BearCare, Inc.
80 Davids Dr. #200
Hauppauge, NY 11788

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: BearCare, Inc
Brand name: Walnut.
Product recalled: Wearable Smart Thermometer
Reason of the recall: Potential for injuries, including skin burns & irritation
FDA Recall date: May 12, 2023

Source: fda.gov See Less

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Lily’s Kitchen is recalling a batch of its Fishy Fish Pie and a batch of Chicken and Turkey Casserole because they may contain pieces of plastic. The possible presence of plastic makes the products unsafe to eat for your pets and presents a potential choking hazard. These... See More products were sold by Pets at Home in the United Kingdom.

The recalled products are:
- Lily’s Kitchen Fishy Fish Pie (400g (Grain Free Wet Adult Dog Food Multipack 24 x 400g cans)), Batch code 1028F, Best before 01 September 2024
- Lily’s Kitchen Chicken & Turkey Casserole (400g (Classic Wet Adult Dog Food Multipack 24 x 400g cans)), Batch code 1032F, Best before 01 September 2024

Pet owners who have bought the affected products, do not feed them to your pets. Instead, contact Lily’s Kitchen for a full refund, with or without a receipt and they will arrange collection of the items from you.

Company name: Lily’s Kitchen
Product recalled: name: Lily’s Kitchen Fishy Fish Pie, name: Lily’s Kitchen Chicken & Turkey Casserole
FSA Recall date: 05/10/2023

Source: food.gov.uk See Less

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SD Biosensor, Inc. is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits). The affected test kits were distributed by Roche Diagnostics... See More to distributors and retailers in the U.S. To date, no such illness has been reported

The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.
Lot Number
53K38N1T1
53K38N2T1
53K38N3T1
53K38N4T1
53K38N5T1
53K38P1T1
53K38P2T1
53K38P3T1
53K41T5T1
53K41X1T1
53K41X2T1
53K41X3T1
53K4211T1
53K4212T1
53K4213T1
53K4221T1
53K4222T1
53K4223T1
53K4224T1
53K4225T1
53K4231T1
53K4232T1
53K4233T1
53K4261T1
53K4262T1
53K4271T1
53K4272T1
53K4273T1
53K4274T1
53K4291T1
53K4292T1
53K42A1T1
53K42A2T1
53K42A3T1
53K42E1T1
53K42G1T1
53K42G2T1
53K42H1T1
53K42H2T1
53K42L1T1
53K42L2T1
53K4361AC
53K4362AC
53K4392AC

Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water and if irritation persists, seek medical attention.

The Pilot COVID-19 At-Home Test is an over-the-counter rapid antigen test and uses a nasal swab sample that can be self-collected and self-tested by individuals ages 14 years and older, and by an adult for children ages 2 to 13 years old.

Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with the contaminated liquid during opening the tube or handling of the open tube or while performing the test.

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: SD Biosensor, Inc.
Brand name: Pilot
Product recalled: COVID-19 At-Home Test
Reason of the recall: Due to microbial contamination in the liquid buffer solution.
FDA Recall date: May 05, 2023

Source: fda.gov See Less

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The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the Quality activities of these marketed products. The discontinuation of the Quality program means the company will not be able to support or... See More guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately. The products were distributed nationwide to Wholesalers, Retailers, Manufacturers, Medical Facilities, and Repackagers and via the Internet to Consumers. Akorn has not received any reports of adverse events related to this recall.

You can see the lists of the recalled products at the following links:
- Human Products: fda.gov
- Veterinary Products: fda.gov

Only products listed in the attachments are affected by the recall. Products not included in the press are continuing to be monitored under a Quality Program and will remain on the market.

Risk Statement: The discontinuation of the Quality program would result in the company’s inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products.

Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites.

Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers / consumers / retailers. Akorn is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.

For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care. For animals drug products, adverse reactions or quality problems experienced with the use of animal drug products may be reported.

Company name: Akorn Operating Company LLC
Brand name: Numerous Brands
Product recalled: Various human and animal drug products
Reason of the recall: As a result of a bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program which would result in the company’s inability to assure that products meet the identity, strength, quality, and purity cha
FDA Recall date: May 04, 2023

Source: fda.gov See Less

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