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Possible false negative Covid-19 test, WA, USA

April 5, 2020 12:00 PM

Washington, United States

Possible false negative Covid-19 test, WA, USA

EIGHTEEN DAYS since I started with virus symptoms.
I may have had a negative Covid-19 test, but I'm 52yrs old & have never been this ill. I have 2 days of fatigue only. Think it's OVER but Fever/EXTREME headache/sore throat/cough just keeps coming back. Unbelievable.

Reported By SafelyHQ.com User

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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
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Reported By SafelyHQ.com User

September 23, 2020 3:00 PM

“Company name: Sun Pharmaceutical Industries
Brand name: Riomet ER
Product recalled: Metformin Hydrochloride for Extended-Release Oral Suspension
Reason of the recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: September 23, 2020
Recall details: Sun Pharmace... See Moreutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.  The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. 

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.  To date, SUN PHARMA has not received any reports of adverse events related to this recall.  RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.  RIOMET ER™, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle.  Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup.  The affected RIOMET ER™ is the following lot:

- RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) 500 mg per 5 mL. Lot # AB06381. NDC #10631-019-17. Expiration Date: 10/2021. Number of Units: 747 cartons.

The product can be identified by the bottles or carton labeled as RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), containing the specific Lot Number and Expiration Date referenced above or on the labeling below. The product was distributed nationwide to wholesale customers.

SUN PHARMA is notifying its distributors and customers through its third-party Recall Coordinator (Inmar Inc.), via FedEx standard overnight shipping and will arrange for return of all recalled products.

Distributors and retailers that have RIOMET ER™ (metformin hydrochloride for extended release oral suspension), which is being recalled, should stop distributing and return it to place of purchase or as directed in the recall notification.

Patients taking RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at fda.gov

Consumers with questions regarding this recall can contact SUN PHARMA by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. 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

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“The CFIA announced the recall of Frank brand Milk Chocolate Covered Raisins by Canadian Tire Corporation of Canada from the marketplace due to undeclared peanut.

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Check the full recall details on the CFIA website: inspection.gc.ca

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September 3, 2020 7:00 PM

“Company name: AJR Trading LLC
Brand name: bio aaa
Product recalled: Hand Sanitizer
Reason of the recall: Possible presence of methanol
FDA Recall date: September 03, 2020
Recall details: AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currentl... See Morey in US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications and tests. However, in an abundance of caution, these units are being recalled because of possible presence of methanol in other lots of bio aaa Advance Hand Sanitizer.

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands may be at risk; young children who accidently ingest them and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, AJR Trading has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer to reduce bacteria when soap and water is not available and is packaged in 480 mL plastic bottles UPC 7502272121085.  AJR Trading is recalling lot 20DF8307, expiration date April 2022. The product can be identified by the images below. Product was distributed in Miami beginning in April 2020. AJR Trading is notifying its customers by phone calls, e-mails, and letters.  AJR Trading is arranging for refund and destruction of recalled products.

Consumers/distributors/retailers that have the above listed lots of bio aaa Hand Sanitizer, which is being recalled, should stop using or distributing the products immediately and mail the products to AJR Trading at the following address for refund: 814 Ponce de Leon Blvd, suite 218. Coral Gables, FL. 33134. Consumers with questions regarding this recall can contact AJR Trading by phone insert 305-302-8416 or e-mail to ajrtrading15@gmaill.com Monday to Friday from 10:00 am to 5:00 pm Central Time.

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

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
See Less
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

September 10, 2020 9:00 PM

“Company name: Pretty Thai
Brand name: Pretty Thai
Product recalled: Pretty Thai Sweat Chili Sauce
Reason of the recall: May contain Pretty Thai Peanut Sauce
FDA Recall date: September 10, 2020
Recall details: Company Announcement Pretty Thai of Austin, Texas, is recalling Pretty Thai Peanut Sau... See Morece that may have been mislabeled as Pretty Thai Sweet Chili Sauce. There is a risk that a person with an allergy or severe sensitivity to peanuts could unintentionally consume a product containing peanuts because of this error. No illnesses have been reported to date.

The product was distributed to H-E-B and Central Market stores in Texas from March 19, 2020 to September 8, 2020. The product is packaged in clear, cylindrical PET bottles with black flip-top caps and clear labels with white print. The recall is for Pretty Thai Peanut Sauce with the Lot Code 0772000123. A small number of the Pretty Thai Peanut Sauce bottles were discovered to have been mislabeled as Pretty Thai Sweet Chili Sauce. Pretty Thai Peanut Sauce is yellow or gold in color, while Pretty Thai Sweet Chili Sauce is dark red in color. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume the mislabeled product.

Pretty Thai and its manufacturer, Ponder Foods, have coordinated efforts with H-E-B to remove all of the affected product from the shelves and from distribution. Out of an abundance of caution, we are alerting consumers in Texas who may have purchased either Pretty Thai Peanut Sauce or Pretty Thai Sweet Chili Sauce to check any product for Lot Code 0772000123. For consumers with no peanut allergy, this Lot Code of Pretty Thai Peanut Sauce, as well as any Lot Code of Pretty Thai Sweet Chili Sauce are completely safe to consume. Product may be returned to H-E-B and/or Central Market for a full refund. Subsequent investigation indicates the problem was caused by a temporary breakdown in the manufacturer's production and packaging processes.

Consumers with questions may contact the Pretty Thai brand directly via email at info@ptfawg.com or via telephone at 512 981 6170. Consumers or retailers may also contact the manufacturer, Ponder Foods, via email at info@ponder-foods.com or via telephone at 469 914 0052 (M-F, 9:00am-5:00pm CDT). Attached below is a photo of the mislabeled product with the affected Lot Code.  

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 1, 2020 4:36 PM

“Fresco Foods Inc. of Tampa, FL is voluntarily recalling ALL units of Ancient Grain Jackfruit Bowl sold at Publix because it may contain an undeclared allergen, FISH (anchovies). People who have an allergy or severe sensitivity to FISH (anchovies) run the risk of serious or life-threatening allergic... See Morereaction if they consume these products.

The allergy alert was initiated after it was discovered that the Ancient Grain Jackfruit Bowl containing Fish was distributed in packaging that did not reveal the presence of fish. Subsequent investigation indicates the problem was caused by sourcing the wrong sub-ingredient.

- Eat Fresco Ancient Grain Jackfruit Bowl. GTIN: 85898800510. Lot/Exp. Date: ALL

Individuals with an allergy or sensitivity to fish (anchovies) should not consume this product. Households that include individuals with an allergy or sensitivity to fish (anchovies) should dispose of the product or return it to the place of purchase for a refund.

Consumers with questions may contact Fresco Foods, Inc. at (813) 551-2100.

Check the full recall details on corporate.publix.com

Source: Publix
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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
See Less
Reported By SafelyHQ.com User