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Amazon Distribution Center - OAK4, 1555 Chrisman Rd, Tracy, CA 95376, USA

Total all time reports:  1
Latest report: April 19, 2020 12:00 PM
Distribution Center worker in Tracy tests positive for COVID-19, Amazon Distribution Center - OAK4, 1555 Chrisman Rd, Tracy, CA 95376, USA

Distribution Center worker in Tracy tests positive for COVID-19

April 19, 2020 12:00 PM

“An employee at the Amazon Distribution Center in Tracy has tested positive for COVID-19, according to a company spokesman.

Source: fox40.com See Less
Reported By SafelyHQ.com User

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“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
Recall details: Marksans Pharma Limi ... See Moreted, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day. 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.

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 8, 2020 12:00 PM

“Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
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Reason of the recall: N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: July 08, 2020
Recall details: Lupin Pharmaceuticals Inc. is voluntarily ... See Morerecalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US. 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 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. Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg is packaged in 60, 90 and 100 count bottles and was distributed nationwide in the US to wholesalers, distributors, drug chain, mail order pharmacies and supermarkets. The recalled NDC’s are included in the table below:

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-338-01 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-339-09 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-336-07 / Distribution Dates: 11/05/2018 - 05/22/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-337-07 / Distribution Dates: 11/05/2018 - 05/22/2020

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chain, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product NDC’s.

Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 1000mg, 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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“Company name: J. M. Smucker Company
Brand name: Natural Balance
Product recalled: Ultra Premium Chicken & Liver Paté Formula
Reason of the recall: Due to elevated levels of choline chloride
FDA R ... See Moreecall date: July 03, 2020
Recall details: The J. M. Smucker Company today announced a voluntary recall of one lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat food due to health concerns likely associated with elevated levels of choline chloride. Ingesting impacted product may cause nausea with excessive salivation, constricted pupils and poor vision, diarrhea or vomiting to more severe symptoms including difficulty walking, muscle shaking, tremors, irregular heartbeat, difficulty breathing, possible cardiac or respiratory failure and, in extreme situations, death. Pet parents are encouraged to contact their cat’s veterinarian immediately if their cat is displaying any of these symptoms.

If pet parents have any product matching the following description in their possession, they should stop feeding it to their cats and dispose of the product. This information can be found on the bottom of each can.

- Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat food (5.5 oz). UPC: 2363353227. Lot code: 9217803. Best by: 08 04 2021

These products are most commonly sold in pet specialty retailers and online throughout the United States and Canada. No other Natural Balance® products are impacted by this recall.

The Company has received reports of adverse reactions. Pet parents that have questions or would like to report adverse reactions should call 888-569-6828, Monday through Friday, 8 a.m. – 5 p.m. ET or email anytime at info@naturalbalanceinc.com.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 3, 2020 2:00 PM

“Company name: IcelandicPlus LLC
Brand name: Icelandic+
Product recalled: Whole Capelin Fish Pet Treats
Reason of the recall: Potential for Clostridium botulinum
FDA Recall date: March 23, 2020
Recall d ... See Moreetails: Out of an abundance of caution IcelandicPlus LLC of Ft. Washington, PA, is recalling its Capelin Pet Treats because some of the fish have exceeded the FDA compliance guideline for fish larger than 5 inches. The FDA has determined that salt-cured, dried, or fermented un-eviscerated fish larger than 5 inches have been linked to outbreaks of botulism poisoning in humans between 1981 and 1987 and again in 1991. Since some IcelandicPlus Capelins are larger than 5 inches there is a possible health risk. To date there have been no reported illnesses of dogs, cats, or persons in connection with Capelin. Nor has there been any positive test results for Clostridium botulinum from any IcelandicPlus Capelin, but because of the potential risk, and despite no known illnesses in connection with our products, we have decided in co-operation with the FDA, to announce this product recall. Clostridium botulinum toxin can cause severe clinical signs including death in both animals consuming the pet treat and people handling the pet treat or coming in contact with contact areas that have been exposed to the product. Common symptoms may include dizziness, blurred or double vision, trouble with speaking or swallowing, difficulty breathing, muscle weakness, abdominal distension, and constipation. Consider that several of the listed symptoms, such as double vision, cannot be easily assessed in animals or conveyed by an animal. Pets or persons experiencing these symptoms should seek immediate medical attention. The Capelin product was shipped to distributors in the United States with the intent to be sold to Retailers who in turn sell to Consumers. This product would be found in Independent Pet Specialty Stores within all States in the United States. The product comes in a clear plastic package or tube, and marked Icelandic+ Capelin WHOLE FISH, PURE FISH TREATS FOR DOGS, or PURE FISH TREATS FOR CATS UPC CODES, 8 5485400775 9; 8 5485400711 7; and 8 5485400757 5 are packaged in a 2.5 ounce tube or a 1.5 or 2.5 ounce bag (lot numbers 02/2020 to 02/2022)IcelandicPlus is family owned and run by pet parents who take the safety and wellbeing of its consumers and clients with the utmost importance, as such we are conducting this voluntarily recall to further protect our customers. Additionally, we are changing our Capelin supplier to ensure that the fish in our product are consistently less than 5 inches, or if larger, they will be completely eviscerated. Distributors, Retailers and Consumers who have purchased IcelandicPlus’s Capelin can return it to the location where it was purchased for a refund.
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User