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Oakland, California, United States

Updated: April 7, 2021 12:00 PM

Covid-19 OSHA Complaint, Learning Without Limits, 2035 40th Avenue, OAKLAND, CA, 94601, USA

Learning Without Limits, 2035 40th Avenue, OAKLAND, CA, 94601, USA

April 7, 2021 12:00 PM

“1. It was confirmed the week of February 22, 2021 that a student was exposed to and contracted COVID-19 while at school on site. There was no communication with the staff or families regarding this incident. T8 CCR 3205(c) 2. The school was not closed for sanitization . T8 CCR 3205(c) 3. Workers wer... See Moree not quarantined. T8 CCR 3205(c)(10)

Alleged Hazards: 3, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-03-05
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Swissport Fueling, Inc., 1 Edward White Way, OAKLAND, CA, 94621, USA

Swissport Fueling, Inc., 1 Edward White Way, OAKLAND, CA, 94621, USA

April 7, 2021 12:00 PM

“1. The employer failed to implement cleaning and disinfecting procedures, which require regularly cleaning and disinfecting frequently touched surfaces. The employer shall inform employees and authorized employee representatives of cleaning and disinfection protocols, including the planned frequency... See Moreand scope of regular cleaning and disinfection. The break rooms are not being regularly cleaned and disinfected and no supplies are provided to the employees. T8 CCR 3205(c)(8)(C)1. 2. The employer failed to provide potable water in adequate supply in all places of employment for drinking and washing and, where required by the employer of these orders, for bathing, cooking, washing of food, washing of cooking and eating utensils, washing of food preparation or processing premises, and personal service rooms. There is no water available for drinking. Only small water bottles are provided occasionally, but not regularly. There is no other supply of drinking water available to the employees other than in an office, but it is closed and many employees do not have access. T8 CCR 3363(a)

Alleged Hazards: 2, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-03-03
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, 24 Hour Oakland Parent Teacher Children Center, 3500 E. 9th Street, OAKLAND, CA, 94601, USA

24 Hour Oakland Parent Teacher Children Center, 3500 E. 9th Street, OAKLAND, CA, 94601, USA

April 7, 2021 12:00 PM

“The employer failed to give notice of the potential COVID-19 exposure, within one business day, to all employees who may have had COVID-19 exposure. The employer failed to offer COVID-19 testing at no cost to employees during their working hours to all employees who had potential COVID-19 exposure i... See Moren the workplace. T8 CCR 3205(c)(3)(B)

Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-02-16
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Reported By SafelyHQ.com User
Vaccine Side Effects Special summary

Covid-19 OSHA Complaint, Craft Industries Inc., 2515 Willow Street, OAKLAND, CA, 94607, USA

Craft Industries Inc., 2515 Willow Street, OAKLAND, CA, 94607, USA

April 7, 2021 12:00 PM

“1. The employer failed to exclude employees who had COVID-19 exposure from the workplace for 10 days after the last known COVID-19 exposure to a COVID-19 case. The employer allowed exposed employees to return to work after obtaining negative PCR test results which were only 2 days after exposure dat... See Moree. Title 8 CCR § 3205(c)(10)(B) 2. The employer required employees to obtain a negative COVID-19 test in order to return to work. Title 8 CCR § 3205(c)(11)(C)

Alleged Hazards: 2, Employees Exposed: 20
Source: Osha.gov | Receipt Date: 2021-02-12
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Alta Bates Summit Medical Center, 350 Hawthorne Ave., OAKLAND, CA, 94609, USA

Alta Bates Summit Medical Center, 350 Hawthorne Ave., OAKLAND, CA, 94609, USA

April 7, 2021 12:00 PM

“1. The employer is failing to maintain their respiratory protection program. The employer is failing to ensure that employees use the proper respiratory protection in the workplace where respirators are necessary to protect the health of the employee. The employer is failing to adhere to an employee... See More's medical doctor's note (02/01/2021) that the employee shall be able to use a PAPR per his request of areas in the hospital instead of an N95 due to his medical condition in relation to possible exposure to COVID-19 in the workplace. T8 CCR 5144(c)(1) and 5144(e )(6)(A) 2. The employer is failing to maintain their respiratory protection program in that certain program elements may be required for voluntary use to prevent potential hazards associated with the use of the respirator. The employer has approved an employee to use a PAPR but is not allowing the employee to use his own, which would ensure prevention of potential hazards, such as cross contamination from one employee to another and risk possible COVID-19 exposure. The employee does have a 3M 300 NIOSH-approved PAPR and does not trust the employer that a shared PAPR would be cleaned properly for use between multiple employees. T8 CCR 5144(c) and 5144(h)(1)(B)

Alleged Hazards: 2, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-02-10
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Reported By SafelyHQ.com User

1st dose of the Moderna vaccine, Oakland, CA, USA

Symptoms: Fatigue Lightheaded Soreness
Oakland, CA, USA

April 5, 2021 6:46 PM

“I am an 84 year old woman who received the 1st dose of the Moderna vaccine on Sat., April 3rd. I had no reaction on that Saturday. The next day my arm was sore at the vaccination site, I was very tired, and light headed, the symptoms disappeared by mid-day and I felt fine the rest of Sunday and feel... See Morefine today. See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Burger King, 4200 International Boulevard, OAKLAND, CA, 94601, USA

Burger King, 4200 International Boulevard, OAKLAND, CA, 94601, USA

April 1, 2021 12:00 PM

“1. The employer is failing to send home employees who report feeling ill or showing signs and symptoms of COVID-19. Employees in November and December reported feeling ill and were asked to take medicine and stay at work. T8 CCR 3205(c)(4) 2. The employer is failing to notify and/or quarantine close... See Morecontacts to employees who were suspected of having COVID-19. Employees in November and December all spent time at home away from work and no employees were notified or quarantined for close contact exposure. T8 CCR 3205(c)(3)(b)(3)(a) 3. The employer is failing to screen employees for signs and symptoms when they come to work. Management does not ask questions if employees are having signs or symptoms. T8 CCR 3205(c)(2)(B) 4. The employer is failing to train employees in the topics of COVID-19, such as social distancing and cleaning of high touch areas. T8 CCR 3205(c)(5) 5. The employer is failing to ensure that all practical solutions are in place to maintain social distancing. The chicken and fry station are in close proximity and sometimes is close to the drive thru station. Management has not adjusted the work schedule to allow for more social distancing. T8 CCR 3205(c)(6)(A) 6. The employer failed to implement a written plan for COVID-19 with policy and procedures. There is not a written plan in place to outline how often areas are cleaned, how often employees are to wash their hands, and how to maintain as much social distancing as possible. T8 CCR 3205(c) 7. The employer is failing to enforce that employees wash their hands frequently while in the workplace. T8 CCR 3205(c)(8)(D) 8. The employer is failing to ensure that high touch areas are cleaned frequently. T8 CCR 3205(c)(8)(C)

Alleged Hazards: 8, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2021-02-26
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Alta Bates Summit Medical Center - Summit Campus, 350 Hawthorne Avenue, OAKLAND, CA, 94609, USA

Alta Bates Summit Medical Center - Summit Campus, 350 Hawthorne Avenue, OAKLAND, CA, 94609, USA

April 1, 2021 12:00 PM

“1. The employer is not providing adequate personal protective equipment to their staff on the 6th floor Medical Surgery Unit when working with patients who have tested positive for COVID-19. T8 CCR 5199(g) 2. The employer does not have a policy in place for employees to determine employee exposure t... See Moreo COVID-19 on the 6th floor Medical Surgery Unit. T8 3203(a)(4) & (6) 3. There is not a designated area/floor for patients that have been confirmed with COVID-19, exposing all staff on the 6th floor Medical Surgery Unit. T8 CCR 3203(a)(4) & (6) 4. Hand sanitizers are not readily available at many locations on the floor. It is not maintained on a regular basis on the 6th floor Medical Surgery Unit. T8 CCR 3203(a)(4) & (6)


Source: Osha.gov | Receipt Date: 2020-07-17
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Alta Bates Summit Medical Center, 350 Hawthorne Avenue, OAKLAND, CA, 94609, USA

Alta Bates Summit Medical Center, 350 Hawthorne Avenue, OAKLAND, CA, 94609, USA

April 1, 2021 12:00 PM

“The employer did not provide new N95 respirators, despite still having supply of new N95 respirators available for use. The employer provided nurses working with COVID-19 in the Telemetry Unit (PCU5) with used, disinfected N95s. T8 CCR Section 5199(g) {Ref Cal/OSHA Interim Guidance on COVID-19 for H... See Moreealth Care Facilities: Severe Respirator Supply Shortages}

Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-07-01
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Alta Bates Summit Medical Center, 350 Hawthorne Avenue, OAKLAND, CA, 94609, USA

Alta Bates Summit Medical Center, 350 Hawthorne Avenue, OAKLAND, CA, 94609, USA

April 1, 2021 12:00 PM

“1. The employer did not provide new N95 respirators, despite still having supply of new N95 respirators available for use. The employer provided nurses working with COVID-19 in the Telemetry unit with used, disinfected N95s. T8 CCR Section 5199(g) {Ref Cal/OSHA Interim Guidance on COVID-19 for Healt... See Moreh Care Facilities: Severe Respirator Supply Shortages} 2. The employer did not communicate with or train nurses regarding changed procedures to provide disinfected masks. T8 CCR 5199(i) and/or 3203(a)(3)

Alleged Hazards: 2, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-07-01
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Reported By SafelyHQ.com User

Recent Interesting Reports

March 26, 2021 7:00 PM

“Company name: Namoo Enterprise LLC
Brand name: PremierZen
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 26, 2021
Recall details: Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling al... See Morel lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil, known as phosphodiesterase (PDE-5) inhibitors, are found in FDA approved products for the treatment of male erectile dysfunction.

The presence of sildenafil and tadalafil in PremierZen Black 5000 products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall. Risk Statement: Consumers with underlying medical issues who take PremierZen Black 5000 with undeclared sildenafil and tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Namoo Enterprise LLC has not received any reports of adverse events related to this recall. The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in card form with one capsule per card and is aware of at least one lot with an expiration date of December 2023. Each pack is black with gold, blue, white and red text. The capsule appears black and is enclosed within clear plastic on the package. The affected lots of PremierZen Black 5000 includes all lots. PremierZen Black 5000 was sold nationwide in the USA via the internet and fulfilled by ebay at www.ebay.com and also fulfilled by amazon at www.amazon.com.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Namoo Enterprise LLC is notifying its customers by this press announcement and by mailing recall letters. Consumers that have PremierZen Black 5000 should stop using and destroy them. Consumers with questions regarding this recall can contact Namoo Enterprise LLC by phone at 201-267-0539, Monday to Friday, 9 A.M. to 5 P.M. EST or email at namooenterprise@gmail.com from Monday to Friday.

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. 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

March 17, 2021 11:00 AM

“Company name: PNHC, LLC d/b/a Heal the World
Brand name: Heal the World
Product recalled: Hand Sanitizer
Reason of the recall: Because they resemble water bottles; risk of ingestion
FDA Recall date: March 17, 2021
Recall details: Raleigh, North Carolina, PNHC, LLC, d/b/a Heal the World, is vol... See Moreuntarily recalling all lots of Heal the World hand sanitizer packaged in 9.6 fl. oz containers to the consumer level. The products are being recalled because they resemble 9.6ounce water bottles. The recall does not affect any other Hand Sanitizer products from PNHC, LLC and/or Heal the World.

- Heal the World Hand Sanitizer (9.6 FL. OZ (285 mL)). NDC: 73333-285-01. Lot Nos. SAA21, SAA24, SAA27, SAA22, SAA23, SAA29, SAA26, SAA28, SAA25, SAA32, SAA55, SAA56, SAA44, SAA60.

To date, PNHC, LLC, d/b/a Heal the World has received no reports of adverse reactions and no complaints have been received. Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 9.6 ounce plastic bottles. The product can be identified by the bottle’s label pictured below. Product was distributed to selected retailers in the United States.

PNHC, LLC has provided notification to its distributors and retailers. Distributors and retailers that have product which is being recalled should stop distribution. While the product is not available for purchase and has not been available for several months, if a consumer has product which is being recalled he or she is advised to contact the entity who sold the product to consumer for return.

Consumers with questions regarding this recall can contact PNHC, LLC at 813-434-0741 from 9:00 am- 5:00 pm EST, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 9, 2021 3:15 PM

“I got the j&j vac at 1:00pm its been 1 hour so far only a slight tingling on vaccination spot other than that nothing big hoping for the best See Less
Reported By SafelyHQ.com User
Vaccine Side Effects Special summary

March 29, 2021 8:00 PM

“Company name: Antoto-K
Brand name: Thumbs Up 7
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 29, 2021
Recall details: Manassas, VA, Antoto-K is voluntarily recalling all lots of Thumbs Up 7 Red 7... See More0K, 10 capsules to consumer level. FDA analysis has found the product to contain undeclared Sildenafil and Tadalafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.

The presence of Sildenafil and Tadalafil in Thumbs Up 7 Red 70K, 10 capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take Thumbs Up 7 Red 70K, 10 capsules with undeclared Sildenafil and Tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Antoto-K has not received any reports of adverse events related to this recall. This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in foil sheet and a box containing 10 capsules. The affected lot numbers of Thumbs Up 7 Red 70K includes all lots. Thumbs Up 7 Red 70K was distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Antoto-K is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have Thumbs Up 7 Red 70K which is being recalled should stop using and destroy them.

Consumers with questions regarding this recall can contact Antoto-K by email at ngtbtr.k17@gmail.com. Consumers should contact their physicians 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. 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

J&J one shot vaccine, Valencia, Santa Clarita, CA, USA

Symptoms: Nausea Fever Headache Chills Soreness
Valencia, Santa Clarita, CA, USA

April 5, 2021 7:15 PM

“Recieved my shot on 4/1/21 @ 2pm. By 10pm had a headache. Middle of the night low grade fever, chills, and nausea. Lasted 48 hours. Now 5 days out and still redess, soreness, and lump at injection site. See Less
Reported By SafelyHQ.com User

March 25, 2021 9:01 AM

“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Antimicrobial Hand Sanitizer
Reason of the recall: Due to microbial contamination
FDA Recall date: March 24, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan announces a voluntary recall of the lot... See Mores listed in the table below of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes listed. The products are being recalled due to microbial contamination. Specifically, out of specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic.

Check the link below for the full list of Durisan Antimicrobial Solutions Hand Sanitizer Sizes and Lot Numbers. To date, no reports of adverse reactions or customer complaints have been reported related to this recall.

The product was packaged in sizes ranging from 18mL credit cards, to bottles sized in 118, 236, 300 and 550 mL and 1000mL wall mounted dispenser refills. Pictures are available in the attached related file.

Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii, can range from no reaction to serious infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available. The product can be identified by examples of the product labels below. The product was manufactured from Feb. 1, 2020 until June 30, 2020, and distributed to selected retailers nationwide in the United States.

Durisan has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. Consumers that have the product which is being recalled are advised to destroy it immediately.

Consumers with questions regarding this recall can contact Durisan at 941-351-9114 [Call: 941-351-9114] , 8:30 am - 4:30 pm Eastern time, Monday through Friday or by e-mail at customerservice@durisan.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

Modern, Merced County, CA, USA

Symptoms: Other Fatigue
Merced County, CA, USA

March 29, 2021 10:43 PM

“First injection:
No issues with injection and no side effects.
Second injection:
Immediately following injection, blood ran down my arm. They claimed that a vein was punctured, but that the vaccination went in just fine. I questioned them again to make sure. And they insisted it was fine. The f... See Moreirst night following injection, my body was uncomfortable and I was unable to get into a deep sleep. 24hrs after injection, the injection site was surrounded by a large patch of red skin that was hot to the touch. At 28 hours, fatigue and malaise set in. At 48hrs, I felt markedly better, although still fatigued. The injection site was much less inflamed. See Less
Reported By SafelyHQ.com User

March 24, 2021 4:00 PM

“Company name: Alembic Pharmaceuticals, Inc.
Brand name: Alembic
Product recalled: Telmisartan Tablets, USP, 20 mg
Reason of the recall: Incorrect Product Strength on Label
FDA Recall date: March 24, 2021
Recall details: Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling on... See Moree lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg.

Risk Statement: Patients who could be on a doubled dose of telmisartan for a prolonged period of time, could experience low blood pressure, worsening of kidney function, or an elevation of potassium which can be life-threatening. To date, Alembic Pharmaceuticals Limited has not received any reports of adverse events related to this recall. The product is used for the treatment of hypertension i.e. to lower blood pressure and is packaged in a bottle of 30 tablets having NDC Number 62332-087-30.

The affected lot of Telmisartan Tablets, USP, 20 mg is the lot number 1905005661 and the lot expires in March 2022. The wrong product can be identified by checking the shape and embossing details on the tablets i.e. Telmisartan Tablets, USP, 20 mg bottles may incorrectly contain oval shaped White to off-white tablets debossed with L203 on one side instead of correct product i.e. round shaped White to off-white tablets debossed with L 202 on one side. Telmisartan Tablets, USP, 20mg, Lot No. 1905005661 was distributed Nationwide in the USA to wholesalers, retailers, and pharmacies.

Alembic Pharmaceuticals Limited is notifying its distributors and retailers through letter and is arranging for return of the recalled lot. Consumers that may have Telmisartan Tablets, USP, 20 mg which is being recalled should not discontinue use until speaking with their pharmacist or healthcare professional for a replacement before returning to place of purchase. Consumers with questions regarding this recall can contact Alembic Pharmaceuticals Inc by phone at +1 908-552-5839 (9:00 am – 5:00 pm, EDT, Monday through Friday) or email address david.cobb@alembicusa.com.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 2, 2021 8:00 PM

“Company name: A-S Medication Solutions, LLM
Brand name: A-S Medication Solutions, LLM
Product recalled: Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles contained in Health Essentials Kits distributed by Humana
Reason of the recall: Products contain an incomplete prescription drug lab... See Moreel
FDA Recall date: April 02, 2021
Recall details: Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is being conducted to the consumer level. These over-the-counter (OTC) analgesic products contain an incomplete prescription drug label rather than the required OTC Drug Facts label.

Risk Statement: Use of acetaminophen could be potentially harmful if safety warnings contained on the OTC label are not observed including: liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol, or are allergic to the active ingredient. To date, the Company has not received any reports of adverse events related to this recall.

The product is used as a pain and fever reliever. The 100-count bottles labeled with NDC 50090-5350-0 are packaged in white plastic bottles contained in a clear plastic bag with other seasonal products labeled as a Health Essentials Kit. Distribution likely occurred between 1/14/21 and 3/15/21 nationwide in the USA. Expiration dates are either 7/31/22 or 8/31/22. The affected bottles that should be returned contain a short Rx drug label that lacks the full OTC Drug Facts chart.

ASM is also notifying its distributors and customers by mail and is arranging for return of all recalled products. Consumers and distributors that have this product which is being recalled should stop using it and return it in preaddressed return mailers that will be provided by ASM or the distributors.

Consumers with questions regarding this recall can contact ASM by telephone at 847.680.3515 x 236, from 9-5 p.m. CST, or e-mail at anel.figueroa@a-smeds.com. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to taking or using this or any 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.

NDC # 50090-5350-0 Lot #s 323206, 323207, 323208, 323209, 323210, 323211, 323212, 323213, 323214, 323215, 323216, 323218, 323219, 323220, 323222, 323223, 323224, 323238, 335353, 335354, 335355, 335356, 335358, 335359, 335360, 335361, 335362, 335363, 335364, 335365, 335366, 33536, 335368, 335369, 335370, 335371, 335372, 335373, 335374, 335375, 335376, 335377, 335395, and 352116.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

Pfizer First Dose Vaccine, Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

Symptoms: Headache Fatigue Soreness
Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

April 2, 2021 7:33 PM

“The vaccine process went relatively smooth. Waited the recommended 15 minutes for any allergic reactions. Had none. My side effects have been mild. Headache, run down feeling, head fogginess, sore arm from where the vaccine was injected, alittle fatigued, and have noticed my heart rate being alittle... See Moretoo high for comfort. See Less
Reported By SafelyHQ.com User