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Hardee's, Army Post Road, Des Moines, IA, USA
Total all time reports:
1
Latest report: June 5, 2020 8:07 AM
More incidents from:
Restaurant
Hardee's
Food Safety
915, Army Post Road
Des Moines
Iowa
United States
Foreign Contaminate
Symptoms: Other
June 5, 2020 8:07 AM
“Foreign objects in coffee. Looked like booger from nose. See Less”
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Products were distributed nationwide to both customers and/or medical facilities. A full list of the affected products with the applicable lot numbers and expiration dates is as follows:
Product Lot/Expiry
Semorelin / Ipamorelin 3mg Lot# SIP210; Exp: 12/15/2021
Lot# SIP215; Exp: 01/14/2022
Lot# SIP220; Exp: 01/23/2022
AOD-9604 3mg Lot# AOD205; Exp: 11/09/2021
Lot# AOD210; Exp: 11/18/2021
Lot# AOD 215; Exp: 12/15/2021
Lot# AOD202; Exp: 11/09/2021
Check the full recall details on fda.gov
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July 1, 2021 6:02 PM
“Company name: Ardil Commercial
Brand name: Limar
Product recalled: Hand sanitizer
Reason of the recall: Packaged in bottles that resemble drink containers
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The product poses a risk of ingestion. Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.
To date, Ardil Comercial has not received any reports of adverse events related to this recall. The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 4 oz bottles. under the brand Limar. The product can be identified by the bottle’s labels pictured below. The affected product lots include the following lot number: 079932-4611-05-J with the following expiration date: May 2022. Hand Sanitizer 4 oz Limar was distributed nationwide to a distributor who may have further distributed nationwide in the USA.
Ardil Comercial is notifying its distributors and customers by telephone, press release and is arranging for a replacement of all recalled products. Consumers and distributors that have the product 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. 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 See Less”
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July 1, 2021 11:00 AM
“Company name: Teva Pharmaceuticals
Brand name: Teva
Product recalled: Topotecan Injection 4 mg/4 mL (1 mg/mL)
Reason of the recall: Presence of particulate matter
FDA Recall date: July 01, 2021
Recall details: Teva Pharmaceuticals has initiated a voluntary recall of lot 31328962B of Topotecan Injection 4 mg/4... See More mL (1 mg/mL), to the retail/institutional level in the United States. This voluntary recall was initiated based on a complaint received from a pharmacy after a single glass particle was observed inside one vial. After further examination of the complaint sample, two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
The administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. While the health hazard risk could be severe if particulate matter is infused, Teva’s internal health assessment determined that the likelihood of patient exposure to impacted product is remote or unlikely.
To date, Teva has received no further complaints or reports of illness or injury.
- Carton NDC: 0703-4714. Vial NDC: 0703-4714-71. Lot# 31328962B. Exp. Date: 04/2022
Topotecan Injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy and for patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. It is also indicated for treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin. It is packaged in 4 mg/4 mL single use vials. The affected product information is listed in the table above. Teva distributed the product nationwide to six of its Wholesale customers.
Teva notified its customers on June 18th 2021 and asked that the lot be recalled and to make arrangements for impacted product to be returned. Any consumer who has questions or concerns should first consult with their health care provider(s).
Check the full recall details on fda.gov
Source: FDA See Less”
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Amphitrite Technology Limited, Purple Sage Lane, Hutto, TX, USA
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July 19, 2021 6:51 PM
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1 person found this review helpful
Scam, Phoenix, AZ, USA
Phoenix, AZ, USA
June 28, 2021 11:46 PM
“Amphitrite Technology Limited. I'm supposed to report a scam that took place. I ordered a wireless power woodcutter and instead I got a metal chain with a ring at each. I paid for something real cheap. Big disappointment!! See Less”
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July 19, 2021 3:02 PM
“Company name: Pfizer
Brand name: CHANTIX
Product recalled: Smoking cessation treatment
Reason of the recall: N-Nitroso Varenicline content above ADI level
FDA Recall date: July 19, 2021
Recall details: Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and... See More eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.
Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. Smoking is also associated with many other cancers. CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options.
To date, Pfizer has not received any reports of adverse events that have been related to this recall.
The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021.
For more recall details including the NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets check: fda.gov
Source: FDA See Less”
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