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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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Undeclared Milk and Soy in Lindt Excellence 85% Cocoa Chocolate Bars, USA

March 19, 2020 2:35 PM

United States

Undeclared Milk and Soy in Lindt Excellence 85% Cocoa Chocolate Bars, USA

Lindt & Sprüngli (USA) Inc. of Stratham, New Hampshire, is issuing a voluntary recall of one lot of its Lindt Excellence 85% Cocoa chocolate bars due to the bars being wrapped in the wrong packaging. The bars are labeled as Excellence 85% Cocoa, but contain Lindt Excellence Dark Caramel Sea Salt bars. Therefore, this product does not contain accurate information about allergens.

Consumers who have a food allergy or have any sensitivity to milk or soy should not consume the product as it could result in a serious or life-threatening allergic reaction.

The recalled Lindt Excellence 85% Cocoa chocolate bars are labeled with Lot Code L5539, a Best Before date of 11-30-2020, and UPC of 3746601645.

For more information go here: fda.gov

Source: FDA

Reported By SafelyHQ.com User
More incidents from:
Allergic Reaction
Recall
United States

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Check the full recall details on fda.gov
Source: FDA
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“Company name: Advanced Bionics
Brand name: HiRes Ultra and Ultra 3D
Product recalled: Cochlear implants
Reason of the recall: Reports of hearing performance degradation
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Recall details: Advanced Bionics (AB), a global leader in developing advanced cochlear implant ... See Moresystems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients.AB's priority is to ensure that all cochlear implant recipients and health care providers have the information they need to understand this situation and that they receive the necessary support. Existing recipients of HiRes Ultra and Ultra 3D may continue to use their device as normal. If recipients experience issues of hearing degradation they should visit their audiologist or other health care provider. In addition, we will begin the notification process for device recipients worldwide, where allowed, to make them aware of the potential issue. This voluntary action is being taken in an abundance of caution in response to recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of February 11, 2020, of the more than 16,000 recipients of these implants, less than 0.5% have been explanted for this reason. Please note that this device-related issue may manifest in performance degradation that could require revision surgery. The only potential for patient harm are the risks associated with a surgery. AB has identified factors that contribute to the clinical symptoms leading to explant and hearing performance degradation. This information will be provided to health care professionals and recipients in geographies that allow. As of February 11th, in the small number of cases that have been explanted, fluid ingress at the electrode has occurred leading to interruption of stimulation. The hermetic seal of the implant case has been shown to be intact. In our efforts to continually improve our products and in response to early reports of this issue AB has developed several improvements to the device to address the issue (new version). AB has received regulatory approval from the FDA in the US and TUV SUD in Europe for these improvements. AB is in the process of submitting these improvements to additional global regulatory agencies. AB plans to distribute products in these geographies as soon as approvals are obtained. AB will continue to distribute the HiRes 90K Advantage cochlear implant as well as the new version of HiRes Ultra and Ultra 3D based on market availability.Previous generations of AB cochlear implants and external sound processors and accessories are not included in the scope of this voluntary field action. AB's primary concern is the safety and hearing performance of our recipients as well as the reliability of our products. AB continues to take all necessary corrective and preventative efforts to address this unforeseen occurrence.
Check the full recall details on fda.gov
Source: FDA
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Check the full recall details on fda.gov
Source: FDA
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Check the full recall details on fda.gov
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Source: FDA
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“Company name: AAA Cosmetica, S.A. de C.V.
Brand name: bio aaa
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Reason of the recall: Potential Undeclared Methanol Contamination
FDA Recall date: July 14, 2020
Recall details: AAA Cosmética, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand ... See MoreSanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). To date, AAA Cosmética has not received any complaints or adverse event reports related to this recall.

The product is used as a hand sanitizer and it is packaged in 480 mL plastic bottles. The product can be identified by the label below. Product was distributed Nationwide in the United States. AAA Cosmetica is recalling the following bio aaa Advance Hand Sanitizer lots, all of which bear the expiration date of April 2022:

20DF9001 / 20DF9002 / 20DF9003 / 20DF9004 / 20DF9005 / 20DF9006
20DF9007 / 20DF9008 / 20DF9009 / 20DF9010 / 20DF9011 / 20DF9012
20DF9013 / 20DF9014 / 20DF9015 / 20DF9016 / 20DF9017 / 20DF9018
20DF9019 / 20DF9020 / 20DF9021 / 20DF9022

Risk Statement: Substantial methanol exposure could result in nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Persons using these products on their hands may be at risk; however young children who accidently ingest them and adolescents and adults who drink these products are most at risk for methanol poisoning.

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Original:
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“Company name: Avet Pharmaceuticals Labs Inc.
Brand name: Heritage
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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.

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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
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June 5, 2020 5:00 PM

“Company name: Marksans Pharma Limited, India
Brand name: Time-Cap Labs, Inc.
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 05, 2020
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Marksans Pharma Limited has not received any reports of adverse events related to this recall to date. Metformin Hydrochloride Extended-Release Tablets, USP 500mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in 100 count bottles with NDC code 49483-623-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side.

Product name: Metformin Hydrochloride Extended Release Tablets USP, 500 mg
Lot #: XP9004
Expiry Date (MM/YYYY): 12/2020

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. nationwide in the USA to wholesalers who further distributed to pharmacies. Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lot.

Distributors/retailers that have Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 which is being recalled should return to place of purchase. 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: FDA
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Reported By SafelyHQ.com User

July 13, 2020 11:27 AM

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Reported By SafelyHQ.com User