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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)

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One employee test positive for Covid-19, 29 E Kings House Rd, Kingston, Jamaica

August 23, 2020 12:00 PM

29 East Kings House Road, Kingston, St. Andrew Parish, Jamaica

One employee test positive for Covid-19, 29 E Kings House Rd, Kingston, Jamaica

One employee at Acropolis Gaming Lounge, on Barbican Centre (Loshusan Mall), Barbican Rd. Kingston in St Andrew Parish tested positive for Covid-19.

Source: jamaica-gleaner.com

Reported By SafelyHQ.com User

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Recent Interesting Reports

August 31, 2020 4:00 PM

“Company name: Mylan N.V.
Brand name: Mylan
Product recalled: Tranexamic Acid and Amiodarone HCl injections
Reason of the recall: Vials potentially packaged in incorrect cartons
FDA Recall date: August 31, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan In... See Morestitutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials.

These batches are being recalled due to the potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. The individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection, USP or Tranexamic Acid Injection, USP. Both of these medications are administered in a hospital setting only by trained healthcare professionals. To date, Mylan has not received any reports of adverse events related to this recall.

Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP are used to treat different conditions. If Tranexamic acid is administered to a patient in place of Amiodarone or vice versa, it could present a risk to patient safety. If Amiodarone HCl Injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower than expected heart rate, which could have immediate life-threatening effects on cardiac function. If treatment with Amiodarone HCl Injection, when needed, is delayed this could result in continued irregular heartbeat and potential life-threatening effects on cardiac function.

If Tranexamic Acid Injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with Tranexamic Acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events. Amiodarone HCl Injection, USP is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients’ refractory to other therapy. Tranexamic acid injection is indicated in patients with hemophilia for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

These batches were distributed nationwide in the USA to wholesalers and hospital/clinical pharmacies between April 2020 and July 2020. The recalled batch information is as follows:

NDC #: 67457-153-09
Material Description: Amiodarone HCl Injection, USP
Strength: 450 mg/9 mL
Carton Size: 10 x 9 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

NDC #: 67457-197-10
Material Description: Tranexamic Acid Injection, USP
Strength: 1000 mg/10 mL
Carton Size: 10 x 10 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

Mylan is notifying its wholesalers and hospital/clinic pharmacies by letter and is arranging for return of recalled products to Stericycle. Wholesalers and hospital/clinic pharmacies that have product which is being recalled should stop use/further distribution or dispensing.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 4, 2020 7:00 AM

“Company name: RLC Labs, Inc
Brand name: RLC Labs
Product recalled: Nature-Throid® and WP Thyroid®
Reason of the recall: Product may be sub potent
FDA Recall date: September 02, 2020
Recall details: RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in... See Moreall strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from  six (6) lots  by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

RLC Labs, Inc. has not received any reports of adverse events related to this recall. Nature-Throid® and WP Thyroid® (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles. To best identify the product, the NDC’s, Product Descriptions, Lot Numbers and Expiration Dates are listed in the link below.

These lots were distributed nationwide in the USA to RLC Labs, Inc.’s direct accounts, including healthcare professionals and retail pharmacies. RLC Labs, Inc. is proactively notifying its wholesalers by email, mail and phone to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking Nature-Throid® and WP Thyroid® should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.

Consumers with questions about the recall can email RLC Labs, Inc. at recall@rlclabs.com or contact RLC Labs, Inc. Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 am to 4:00 pm MST (AZ) and Friday from 7:00 am to 3:00 pm MST (AZ). 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.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

August 28, 2020 7:04 PM

“Mayor Hancock was photographed on June 3, maskless, arm in arm with BLM protestors after mandating mask wearing for the City of Denver. This is a violation of his own rules, putting the lives of all of those children, his staff, and his family at risk. Shameful behavior. See Less
Reported By SafelyHQ.com User

August 26, 2020 4:00 PM

“Company name: Nanomateriales, SA de CV
Brand name: Zanilast+
Product recalled: Hand sanitizer
Reason of the recall: Product contains 1-propanol.
FDA Recall date: August 26, 2020
Recall details: Apodaca, Nuevo Leon, Nanomateriales is voluntarily recalling all lots of ZANILAST+ GEL, Sanitizer gel... See More, to the consumer level. FDA laboratory analysis found ZANILAST+ GEL to contain 1-propanol.

Risk Statement: There is a reasonable probability of acute toxicity from ingestion which can cause central nervous system depression, which could result in death, permanent impairment, or necessitate medical or surgical intervention. Populations most at risk include individual with alcohol addiction and adolescents, who have been known to ingest ethanol-based antiseptic rubs intentionally to become intoxicated, as well as infants and children who may unintentionally ingest the defective product.

Nanomateriales, SA de CV has not received any reports of adverse events related to this recall. The product is used as a sanitizer gel, for hand washing to decrease bacteria on the skin and is packaged in 1 liter, 25 liters, and 1 gallon plastic bottles distributed from 05/29/2020 to 06/17/2020 in the States of California, New York and New Jersey.

Presentatio UPC NDC Lable
1 Liter 2 000000 531151 69912-008-01 See below
25 Liter 2 000000 531151 69912-006-01 See below
1 galon 2 000000 531144 69912-008-02 See below

Nanomateriales, SA de CV is notifying its distributors and customers by e-mail and phone and is arranging for return of all recalled products. Consumers and distributors that have ZANILAST+ GEL which is being recalled should return to place of purchase.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 17, 2020 11:00 PM

“Company name: Acella Pharmaceuticals, LLC
Brand name: NP Thyroid 15 & NP Thyroid120
Product recalled: Thyroid Tablets
Reason of the recall: Sub Potency
FDA Recall date: September 17, 2020
Recall details: Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg... See MoreNP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updates.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall. NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images. To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Additionally, consumers may be able to determine that their product is not impacted by the recall if the “use by,” “discard after,” or “expiration date” on their prescription bottle is on or after December 2020.

Product NDC Lot # Exp. Date
NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg) 42192-327-01 M327E19-1 October 2020
NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg) 42192-328-01 M328F19-3 November 2020

Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the two above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

September 1, 2020 4:38 PM

“The FSIS announced the recall of approximately 1,202 pounds of ready-to-eat (RTE) chicken salad product by Ukrop’s Homestyle Foods due to misbranding and an undeclared allergen. The product may contain almonds, a known allergen, which are not declared on the product label.

The RTE chicken salad i... See Moretem was produced on August 26, 2020. The following product is subject to recall:

- 15-oz. round plastic containers containing “Ukrop’s Chicken Salad” with a sell by date of “09/02/20”.

The product subject to recall bears establishment number “P-19979” inside the USDA mark of inspection. These items were shipped to retail locations in North Carolina, Ohio, Virginia, and West Virginia. The problem was discovered after the firm received a consumer complaint reporting that the product contained almonds.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

FSIS is concerned that some product may be in retailer and consumers’ refrigerators. Retailers who have obtained these products are urged not to sell them. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers. Consumers and members of the media with questions about the recall can contact Susan Rowe, Executive Administrator, Ukrop’s Homestyle Foods, at (804) 340-3050.

Check the full recall details on the FSIS website fsis.usda.gov

Source: FSIS
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Reported By SafelyHQ.com User

September 2, 2020 8:00 PM

“Company name: Sunshine Mills, Inc.
Brand name: Family Pet, Heartland Farms, Paws Happy Life
Product recalled: Dog Food
Reason of the recall: Elevated levels of aflatoxin
FDA Recall date: September 02, 2020
Recall details: Sunshine Mills, Inc. is issuing a voluntary recall of certain dog food pr... See Moreoducts due to levels of Aflatoxin that are potentially above the acceptable limit.  Aflatoxin is a naturally occurring mold by-product from the growth of Aspergillus flavus and can be harmful to pets if consumed in significant quantities. The potential for aflatoxin levels above the acceptable limit in these products was discovered by routine sampling performed by the Louisiana Department of Agriculture and Forestry showing that a sample of a single 4-pound bag of one lot of the product contained elevated levels of aflatoxin. 

No illnesses have been reported in association with these products to date, and no other Sunshine Mills, Inc. pet food products are affected by this announcement. While no adverse health effects related to these products have been reported, Sunshine Mills, Inc. has chosen to issue a voluntary recall of these products as a precautionary measure in furtherance of its commitment to the safety and quality of its products. 

Pets that have consumed any of the recalled products and exhibit symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian. The affected products were distributed in retail stores nationally.  Retailers who received the recalled lots have been contacted and asked to pull these lots from their inventory and shelves. 

There are no other Family Pet®, Heartland Farms®, or Paws Happy Life® products or other lot codes of these products affected by this precautionary recall. Consumers who have purchased the recalled products should discontinue use of the product and may return the unused portion to the place of purchase for a full refund.

Consumers may contact Sunshine Mills, Inc. Customer Service at (800) 705-2111 from 7AM to 4PM Central Time, Monday through Friday, or by email at customer.service@sunshinemills.com for additional information. This is a voluntary recall being conducted in cooperation with the U.S. Food and Drug Administration. Products affected by this announcement:

+ Family Pet® Meaty Cuts Beef Chicken & Cheese Flavors Premium Dog Food.
- UPC: 3225120694. Size: 4 Lb. Lot codes: TD3 4/April/2020 | TD1 5/April/2020.
- UPC: 3225118078. Size: 14 Lb. Lot codes: TB1 4/April/2020 | TB2 4/April/2020 | TB3 3/April/2020
- UPC: 3225120694. Size: 28 Lb. TB3 3/April/2020
+ Heartland Farms® Grilled Favorites. Beef Chicken & Cheese Flavor.
- UPC: 7015514299. Size: 14 Lb. Lot codes: TB1 4/April/2020 | TB2 4/April/2020
- UPC: 7015514301 Size: 31 Lb. Lot codes: TA2 4/April/2020 | TA3 4/April/2020
+ Paws Happy Life® Butcher’s Choice Dog Food
- UPC: 3680035763. Size: 16 Lb. Lot codes: TA1 4/April/2020 | TA2 4/April/2020

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

August 25, 2020 8:00 AM

“Company name: Sunshine Mills, Inc.
Brand name: Nature’s Menu
Product recalled: Nature’s Menu Super Premium Dog Food with a Blend of Real Chicken & Quail
Reason of the recall: Salmonella
FDA Recall date: August 24, 2020
Recall details: Sunshine Mills, Inc. is issuing a voluntary recall of Nature... See More’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail because of the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The recalled products were distributed in retail stores nationally and can be identified with the following UPC 7015514363 and UPC 7015514365.

- The product comes in a 3-pound bag with the following lot codes:
TE1 20/April /2020, TE1 21/April/2020, TE1 22/April/2020, TE2 20/April /2020, TE2 21/April/2020, TE2 22/April/2020, TE3 20/April/2020, TE3 21/April/2020, TE3 22/April/2020.

- The product comes in a 13.5-pound bag with the following lot codes:
TB1 20/April /2020, TB1 21/April/2020, TB1 22/April/2020, TB2 20/April /2020, TB2 21/April/2020, TB2 22/April/2020, TB3 20/April/2020, TB3 21/April/2020, TB3 22/April/2020.

No illnesses, injuries or complaints have been reported to date. There are no other Nature’s Menu® products or other lot codes of the Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail affected by this precautionary recall. The potential for contamination was noted after the firm was notified by the Georgia Department of Agriculture when a sample of a single 3-pound bag of the product was collected and tested positive for Salmonella. 

The firm conducted testing of multiple samples of the same lot which all tested negative for Salmonella. Salmonella may not be evenly distributed throughout a lot which is why it could have been found on one sample and not on multiple other samples of the same lot.  However, out of an abundance of caution, Sunshine Mills, Inc. has chosen to issue a voluntary recall of the above-referenced lots of Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail in furtherance of its commitment to the safety and quality of its products. Retailers who received the recalled lots have been contacted and asked to pull these lots from their inventory and shelves. 

Consumers who have purchased Nature’s Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail from the recalled lots should discontinue use of the product and may return the unused portion to the place of purchase for a full refund. Consumers may contact Sunshine Mills, Inc. customer service at (800) 705-2111 from 7AM to 4PM Central Time, Monday through Friday, or by email at customer.service@sunshinemills.com for additional information.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Salmonella

September 1, 2020 6:14 PM

“Company name: The Protein Shoppe, LLC
Brand name: Red-E
Product recalled: Red-E male enhancement tablet
Reason of the recall: Product contains undeclared sildenafil
FDA Recall date: September 01, 2020
Recall details: Company Announcement The Protein Shoppe, LLC is voluntarily recalling all lots... See Moreof “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction.

The presence of sildenafil in Red-E renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. The undeclared PDE-5 inhibitor in the product may pose serious health risks to consumers with underlying medical issues. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that is life threatening and could result in serious adverse health consequences. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date The Protein Shoppe, LLC has not received any reports of adverse events related to this recall. The product, Red-E (Male Enhancement tablet), is marketed as a male enhancement nutritional supplement, the product is a scored octagonal tablet with “Red” embossed on either side of the score line on one side of the tablet which is contained in small plastic bag with a black label stapled to it, UPC. The Red-E pill was sold online at the website: www.rgvproteinshoppe.com.

The Protein Shoppe, LLC is notifying its customers with this press release and is arranging for return of all recalled products. Consumers that have The Red-E pill (male enhancement tablet), which is being recalled, should stop using and return to place of purchase. Consumers with questions regarding this recall can contact The Protein Shoppe by phone at 956-687-3539, Monday through Friday from 10 AM to 6 PM CST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 11, 2020 4:00 PM

“Company name: Goodie Girl Tribeca LLC
Brand name: Goodie Girl
Product recalled: Goodie Girl GF Magical Animal Crackers
Reason of the recall: May Contain Undeclared Wheat
FDA Recall date: September 11, 2020
Recall details: Goodie Girl Tribeca LLC announced today it is voluntarily recalling 389... See Morecases of a single date code of 7 oz. Goodie Girl Magical Animal Crackers, with a “best by” date of Jan 11, 21A3, after learning that the product may contain undeclared wheat ingredients. People who have an allergy or severe sensitivity to wheat run the risk of allergic reaction if they consume the product contained in the recalled boxes. There has been an individual with a wheat allergy that was treated for a wheat allergen reaction.

This recall affects only 389 cases of the following product, which were distributed in retail stores nationwide:
- Description; Goodie Girl GF Magical Animal Crackers
UPC# 8-5598700395-3
Size; 7 Ounces
Best By Date; Jan 11, 2021
Distributed between 4/17/2020 – 5/7/2020

This recall does not apply to any other “best by” dates, sizes or varieties of Goodie Girl Tribeca LLC. This recall was initiated in cooperation with the FDA and the third-party co-packer that produced the product. Product with this particular “best by” date was shipped and distributed by Goodie Girl Tribeca to its customers' warehouses located in Virginia, Pennsylvania, Georgia, New Hampshire, California. Consumers seeking a refund or additional information may contact info@goodiegirl.com or call 201-941-2000 9am – 5pm est.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User