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Rehab Select at Shelby Ridge, 881 3rd St NE, Alabaster, AL 35007, USA

Total all time reports:  1
Latest report: April 21, 2020 12:00 PM
15 test positive for COVID-19 at nursing home, Rehab Select at Shelby Ridge, 881 3rd St NE, Alabaster, AL 35007, USA

15 test positive for COVID-19 at nursing home

April 21, 2020 12:00 PM

“15 people tested positive for the coronavirus at Shelby Ridge nursing home.

Source: abc3340.com See Less
Reported By SafelyHQ.com User

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April 20, 2020 4:00 PM

“Company name: Fresenius Kabi USA, LLC
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL
Reason of the recall: Presence of Particulate Matter
FDA Recall date: April 20, 2020
Recall details: Freseni ... See Moreus Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen, and polyamides.

Particulate matter was found in eight reserve sample vials. Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days. Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:

- Ketorolac Tromethamine Injection, USP, 30 mg / mL, 1 mL fill in a 2 mL amber vial. NDC: 63323-162-01. Product code: 160201. (Check the recall notice for specific batch numbers)
- Ketorolac Tromethamine Injection, USP, 60 mg / 2 mL (30 mg / mL), 2 mL fill in a 2 mL amber vial. NDC: 63323-162-02. Product code: 160202. (Check the recall notice for specific batch numbers)

Check the full recalled product list and details on fda.gov

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“Company name: Amneal Pharmaceuticals LLC
Brand name: Amneal
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FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall. Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by 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 found in water and foods, including meats, dairy products, and vegetables. Metformin HCl Extended-Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended-Release Tablets, USP, 500 mg
53746-178-01. 100 count bottles
53746-178-05. 500 count bottles
53746-178-10. 1000 count bottles
53746-178-90. 90 count bottles
53746-178-Bulk. Bulk Box
65162-178-09. 90 count bottles
65162-178-10. 100 count bottles
65162-178-11. 1000 count bottles
65162-178-50. 500 count bottles

Metformin HCl Extended-Release Tablets, USP, 750 mg
53746-179-01. 1000 count bottles
53746-179-Bulk. Bulk Box
65162-179-10. 100 count bottles

The affected Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers, and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for the return of all the recalled products. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Check the full recall details on fda.gov

Source: FDA
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“Company name: Becca Cosmetics
Brand name: Becca Cosmetics
Product recalled: Light Shifter Brightening Concealer
Reason of the recall: Potential Mold
FDA Recall date: May 07, 2020
Recall details: Company Announcement Out of abundance of caution, and in line with its commitment to consumer sat ... See Moreisfaction and safety, Becca Cosmetics is voluntarily recalling all shades of its Light Shifter Brightening Concealer because a brownish-black material identified as a common household mold was found on the sponge-tip applicator of some units. While this is unlikely to cause serious injury there is a potential risk of temporary skin and/or eye allergy and irritation.

To date, no adverse reactions or injuries have been reported. This product was manufactured in the United States and distributed nationwide. The below are the details of the product affected by this recall. No other Becca Cosmetics products are affected by this issue.

- Product Name: Becca Cosmetics Light Shifter Brightening Concealer
- Batch: 0030A, 9308A, 0052A, 0052C, 9291A, 9309A, 0036A, 0037A, 0038A, 0038B, 0041A, 9289A, 0062A, 0062B, 0062C, 9283A, 9284A, 9287A, 9288A
- Size: 3.2 mL (only size available)
- Product Description: Concealer wand with silver overlay, and a white secondary carton
- UPC: 9331137030037, 9331137030044, 9331137030051, 9331137030068, 9331137030075, 9331137030099, 9331137030082, 9331137030105

If you have this product, please stop using it and contact the place of purchase regarding a refund. 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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June 23, 2020 8:01 PM

“Company name: Golden Nutrition Inc.
Brand name: Golden Nutrition Inc.
Product recalled: Anti-Viral Immune Enhancement Capsules
Reason of the recall: Unsubstantiated Health Claims on Label
FDA Recall date: June 23, 2020
Recall details: Golden Nutrition Inc. of Opa Locka, Florida is recalling fou ... See Morer (4) Lots of Anti-Viral Immune Enhancement Capsules because the label makes unsubstantiated health claims. The recalled Anti-Viral Immune Enhancement were distributed to distributors through orders. The distribution is in Puerto Rico where consumers are able to get the product via retailers.

The product of 60 capsules comes in a green 150cc PET Bottle, with a gold cap marked with lot and expiration number on the bottom of the bottle. The Lot and expiration numbers that are being recalled are the following: Lot:1493 with Expiration: 04/2023, Lot:1499 with Expiration: 04/2023, Lot:1513 with Expiration:05/2023, and Lot:1515 with Expiration 05/2023.  

No illnesses have been reported to date in connection with this problem.

The noncompliance with FDA regulations for label claims was noted after one of our distributors brought it to our attention. The label makes unsubstantiated health claims that the product “helps fight corona virus and influenza.” Consumers that use this product instead of seeking medical treatment run the risk of serious, life threatening health consequences. The production of the product has been suspended while the company works to correct the label. Consumers who have purchased the Anti-Viral Immune Enhancement are urged to return them to the place of purchase for a full refund.

Check the full recall details on fda.gov

Source: FDA
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