I might have VERY mild COVID-19 symptoms, San Francisco, CA, USA

July 12, 2020 12:00 PM

San Francisco, California, United States

Symptoms: Fever Other Chills

I think I might have VERY mild COVID-19 symptoms.

1st night had mild chills, 4 days of occasional stomach uneasyness, exhaustion, and 97F-96F temp.

Today a bit of post-nasal drip, nose is clear but stuffed up - sinuses feel stuffed up.

and my back and neck are now stiff.

September 28, 2020 12:00 PM

“The establishment was not cleaned after several employees tested positive for COVID-19.


Source: Osha.gov | Receipt Date: 2020-08-20See Less”

September 28, 2020 12:00 PM

“1. The employer has not identified and implemented necessary workplace controls (engineering, administrative, work practices) to reduce employee exposure to the COVID-19 virus such as barrier sneeze guards, additional training, social distancing practices, increased cleaning, utilization of face cov... See Moreerings and masks, etc. per OSHA publication # 3990-3 2020 osha.gov and CDC guidelines.

2. The employer has not identified specific type(s) of personal protective equipment (PPE) (i.e. gloves, masks, etc.) that need to be available to reduce employee exposure to the COVID-19 virus.

3. Adequate infection control prevention policies and procedures are not being implemented and enforced to avert the spread of the COVID-19 virus as employees are not required to wear face coverings and/or masks.



Source: Osha.gov | Receipt Date: 2020-07-29See Less”

September 28, 2020 12:00 PM

“1. Social distancing is not enforced during morning carrier meetings and safety talks given on the workroom floor.

2. Social distancing is not enforced when multiple employees need to interact with a supervisor such as when approximately 20 carriers were gathered around the supervisor's desk on L... See Moreabor Day to choose a route for the day.

3. Employees and supervisors are not wearing face masks or are wearing them pulled down below their nose and mouth when social distancing is not maintained as in complaint items 1 and 2 and when carriers meet with their supervisors in the workroom after returning from their daily route.

Alleged Hazards: 1, Employees Exposed: 20
Source: Osha.gov | Receipt Date: 2020-09-11See Less”

September 28, 2020 12:00 PM

“Serious

Alleged Hazards: 1,
Source: Osha.gov | Receipt Date: 2020-08-18See Less”

September 28, 2020 12:00 PM

“1. Unsafe working regarding conditions related to coronavirus.
2. No masks, hand sanitizer or social distancing.



Source: Osha.gov | Receipt Date: 2020-08-24See Less”

September 28, 2020 12:00 PM

“1. When the conveyors stop, boxes are backing up onto the floor causing a trip hazard.
2. The same boxes are blocking employee's emergency exit routes.
3. The facility is not following the Governor's guidelines for preventing the spread of COVID-19.


Hazard Location:
1. In AFV1 Packing... See MoreDepartment.

6/11/2020
HD

Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-06-10See Less”

September 28, 2020 12:00 PM

“The employer did not maintain an effective Injury and Illness Prevention Program in that the employer did not ensure that COVID-19 precautions per the state executive and local public health department orders are being followed at the workplace in the following instances:

1. The employer did not... See Moreimplement individual control measures and screenings. T8 CCR 3203(a)(6).

2. The employer did not implement disinfecting protocols. T8 CCR 3203(a)(6).

3. The employer did not implement physical distancing guidelines. T8 CCR 3203(a)(6).


Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-07-13See Less”

September 28, 2020 12:00 PM

“Alleged Hazard: There is a COVID case and its being kept a secret from her.

Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-08-16See Less”

September 28, 2020 12:00 PM

“1. The mask mandate is not being enforced for vendors (Hallmark) coming into the store. One vendor employee was not wearing any facial covering while working in the store. Walmart management was informed about the employee and did not enforce mask policy.

Alleged Hazards: 1, Employees Exposed:... See More200
Source: Osha.gov | Receipt Date: 2020-08-25See Less”

September 28, 2020 12:00 PM

“An employee(1) at KLINGER CONSTRUCTORS LLC in ALBUQUERQUE, NM tested positive for Covid-19. Event Date: 09/25/2020, RR-1505

Source: env.nm.govSee Less”

September 7, 2020 8:36 PM

“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.

- Frank Milk Chocolate Covered Raisins (300 g). UPC: 6 26394 33920 7. Best Before 2021 MA 07, Lot: 07EUA | Best Before 2021 MA 13, Lot... See More: 13EUA | Best Before 2021 JL 07, Lot: 07GUB | Best Before 2021 APR 21, Lot: 21DUB | Best Before 2021 JL 08, Lot: 08GUB

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

Source: CFIASee Less”

September 16, 2020 9:38 PM

“The FSIS announced the recall of approximately 6,890 pounds of ready-to-eat (RTE) chicken salad products by Willow Tree Poultry Farm, Inc due to misbranding and an undeclared allergen. The products may contain walnuts, a known allergen, which are not declared on the product labels. There have been n... See Moreo confirmed reports of adverse reactions due to consumption of these products to date.

FSIS advises consumers not to eat the recalled products and to throw them away or return them to the place of purchase. The RTE chicken salad product labeled as “Classic Chicken Salad” may actually contain “White Meat Cranberry Walnut Chicken Salad” and was produced on Sept. 2, 2020. The products subject to recall bear establishment number “EST. P-8827” inside the USDA mark of inspection. These items were shipped to retail locations in Connecticut, the District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, Rhode Island, Vermont and Virginia. The following products are subject to recall:

- 15-oz. clear, plastic containers labeled as “Willow Tree Premium White Meat CHICKEN SALAD Classic” with a sell by date of “9/30/20” and a time stamp of 13:00:00 through 17:00:00 on the containers’ cellophane lid.

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

Source: FSISSee Less”

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: FDASee Less”

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: FDASee Less”

September 5, 2020 12:03 PM

“Midgets in restaurant flying over my food, disgusting, waiter said it’s “nature”See Less”

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: FDASee Less”

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: FDASee Less”

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

Source: FDASee Less”

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: FDASee Less”

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: FDASee Less”