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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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Define fitness, Albuquerque, NM, USA

Total all time reports:  1
Latest report: March 16, 2020 7:28 PM
Woman had Coronavirus and was around a lot of people, Define fitness, Albuquerque, NM, USA

Woman had Coronavirus and was around a lot of people

March 16, 2020 7:28 PM

“She was sick and went to get tested and they confirmed she is quarantine they sent us a email telling us to get checked or call our doctor. Was around a lot of people at least around 5 to 10 people See Less
Reported By SafelyHQ.com User

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Brand name: Gemini Laboratories
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Reason of the recall: NDMA (Nitrosodimethylamine) impurity
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Recall details: Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is volunt ... See Morearily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. Risk Statement: 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. Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:

- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06598004A. Expiration Date: 04/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599001A. Expiration Date: 12/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599002A. Expiration Date: 12/2020

The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Check the full recall details on fda.gov

Source: FDA
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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
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The FDA guidelines address 4 specific areas:
1) *Monitor Employee Health* - Management must instruct employees to speak up about possible COVID-19 symptoms or exposure and implement workplace controls to screen and reduce possible transmission. Workplace controls can include: Pre-screening employees for high temperatures, increase disinfecting and cleaning of workspaces and equipment, wearing personal protective equipment (PPE) such as face mask and gloves, and practicing social distancing of at least 6 ft when possible.
2) *Emphasize Personal Hygiene for Employees* - When working, employees must wash their hands with soap and water for at least 20 seconds especially after using the bathroom, before eating, and after blowing your nose, coughing, or sneezing. If soap is not available, employees must use an alcohol-based sanitizer with at least 60% alcohol. Employees should also avoid touching exposed food or surfaces with their bare hands and need to always wear gloves.
3) *Follow and Enhance Food Safety Protocols* - Food establishments must follow established food safety protocols such as cooking foods to the proper temperature and separating raw and cooked ingredients. In addition to standard safety protocols, establishments need to increase safety measures to help customers maintain infection prevention by encouraging spacing in lines, discontinuing salad bars and buffets, and discouraging bringing pets into stores.
4) *Manage Food Pick-Up and Delivery* - For food pick-up, establishments need to create protocols to allow customers to maintain social distancing and maintain food safety standards. FDA recommends the creation of designated pick-up zones to allow for customers to maintain proper social distancing. For delivery, no-contact delivery and customer communication via Text and calls should be enacted.

This is not a comprehensive list and is only best practice guidelines from the FDA. If you spot issues or violations, please report at https://safelyhq.com/tag/coronavirus-covid-19

To review the in-depth guidance from the FDA please go here: fda.gov

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Reported By SafelyHQ.com User

April 16, 2020 3:00 PM

“Company name: Avet Pharmaceuticals Labs Inc.
Brand name: Heritage
Product recalled: Tetracycline HCl Capsules, 250mg and 500mg
Reason of the recall: Due to low out of specification dissolution results
FDA Recall date: April 16, 2020
Recall details: Avet Pharmaceuticals Inc. (“Avet”), based in ... See MoreEast Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.

- Tetracycline HCl Capsules 250 mg 100 count. NDC number: 23155-017-01. Lot No: H190666. Expiry Date: JUL 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190609. Expiry Date: JUN 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190610. Expiry Date: JUN 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190611. Expiry Date: JUN 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: L191027. Expiry Date: NOV 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: L191028. Expiry Date: NOV 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: K190953. Expiry Date: OCT 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: K190952. Expiry Date: OCT 2022

These drug products are manufactured by Avet Pharmaceuticals Labs Inc. and distributed under the Heritage Pharmaceuticals Inc. label. The voluntary recall is being initiated due to low out of specification dissolution test results.

Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.

The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors Nationwide in United States between August 2019 and March 2020.

Avet is notifying its distributors and customers by a separate notification to distributors and through Qualanex and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User