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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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Lake Crossing Health Center, 6698 Washington Rd, Appling, GA 30802, United States

Total all time reports:  1
Latest report: April 21, 2020 12:00 PM
Cases of COVID-19 in Health Center, Lake Crossing Health Center, 6698 Washington Rd, Appling, GA 30802, United States

Cases of COVID-19 in Health Center

April 21, 2020 12:00 PM

“In Columbia County, two employees have tested positive at Lake Crossing Health Center. No residents have tested positive. There are 92 total residents.

Source: wrdw.com See Less
Reported By SafelyHQ.com User

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“Company name: Avet Pharmaceuticals Labs Inc.
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Reason of the recall: Due to low out of specification dissolution results
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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.

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- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190609. Expiry Date: JUN 2022
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- 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

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“Company name: Lupin Pharmaceuticals, Inc
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FDA Recall date: June 11, 2020
Recall details: Lupin Pharmaceuticals Inc. is voluntarily recalling Met ... See Moreformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

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. Metformin Hydrochloride Extended-Release Tablets USP, 500mg is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in a bottle containing 60 tablets with NDC 68180-336-07. The affected lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg is included in below table:

- Product Name: Metformin Hydrochloride Extended-Release Tablets USP, 500mg

- NDC: 68180-336-07

- Lot Number: G901203

- Expiration Date: 12/2020

The product can be identified by the NDC and the lot number available on the side of the bottle label. Metformin Hydrochloride Extended-Release Tablets USP, 500mg was distributed nationwide in the USA to wholesalers, distributors, and mail order pharmacies.

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product lot. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 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.

Check the full recall details on fda.gov

Source: FDA
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May 20, 2020 10:00 PM

“Company name: Biota Biosciences, LLC
Brand name: Biota Biosciences
Product recalled: Cannabidiol (CBD) Complex, Curcumin Complex, Cannabidiol + Curcumin
Reason of the recall: Unapproved new drug
FDA Recall date: May 20, 2020
Recall details: Biota Biosciences is voluntarily recalling the followi ... See Moreng lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level. These injectable products are being recalled because they were marketed without FDA approval. The products claims on our website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use.

- Product Name: Cannabidiol(CBD)Complex / Strength(mg): 40 / Multiple Dose Vial Size: 10 mL / Lot: 2H071219P / Expiration: 07/12/2021

- Product Name: Cannabidiol(CBD)Complex / Strength(mg): 500 / Multiple Dose Vial Size: 10 mL / Lot: 10102019P / Expiration: 10/10/2021

- Product Name: Curcumin Complex / Strength(mg): 40 / Multiple Dose Vial Size: 10 mL / Lot: 2H071219CCD / Expiration: 07/12/2021

- Product Name: Curcumin Complex / Strength(mg): 500 / Multiple Dose Vial Size: 10 mL / Lot: 0712019CCD / Expiration: 07/12/2021

- Product Name: Cannabidiol + Curcumin / Strength(mg): 500 / Multiple Dose Vial Size: 10 mL / Lot: 10102019PC / Expiration: 10/10/2021

Risk Statement: Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Biota Biosciences has not received any reports of adverse events related to this recall.

Risk Statement: Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Biota Biosciences has not received any reports of adverse events related to this recall.

Cannabidiol (CBD) Complex was marketed to suppress pain and aid in the detoxification processes as a promising therapeutic for a wide array of disorders such as epilepsy, including many challenging neuropathy conditions. Curcumin Complex was marketed as a potent anti-inflammatory and antioxidant that may also help improve symptoms of depression and arthritis. Cannabidiol + Curcumin was marketed as a more efficient therapeutic effect. The product was sold to certified practitioners who further administer to customers. The product is packaged in 10 mL sterile vials. Products were distributed Nationwide in the USA and one consignee in New Zealand.

Water Soluble 40mg/10m products can be identified by the labels attached.

Water Soluble 500mg/10m products can be identified by the labels attached.

Check the full recall details on fda.gov

Source: FDA
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