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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

Foreign Contaminate

Symptoms: Other

June 5, 2020 8:07 AM

“Foreign objects in coffee. Looked like booger from nose. See Less
Reported By SafelyHQ.com User

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Recent Interesting Reports

July 14, 2021 7:27 PM

“I have had this bait and switch happened to me twice, once by this company and once by another company. The little wires are used by campers to cut small branches. Both times. I paid through PayPal. I ordered the rechargeable battery mini saw pruner. I received... See More a wire. Contacted the seller and the seller offered me a 50% refund, I told the seller I wanted 100% of my money back. The seller then replied that he would request a 60% refund but he could not give back 100% unless I returned the product to China. It costs like 30 dollars to send to China from the US even though they claim they are US based. The seller said they had shipped product and paid logistic cost to ship it to me and would I please accept the 60% and he hoped I understood. These bait and switch practices are illegal in the US. I escalated the case to Paypal. Then waited for the review. I then received an email from PayPal stating the seller had provided a shipping number and they found in favor of the seller. This message is generated by an auto responder. I then called PayPal and requested to speak to a PayPal agent. With in 2 minutes the person could see the Seller had done this over and over. They refunded my money and apologized for the inconvenience the Seller had caused me. It takes some time and effort, but persistence pays off. Also, it I s not your responsibility to return the product they shipped back to them at your expense.

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Reason of the recall: Potential lack of sterility assurance
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Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening. To date, Innoveix Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.

The affected products are injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg. The products can be used for various indications as prescribed. The products can be identified by an Innoveix Pharmaceuticals, Inc. label. The products were distributed in glass vials contained in a small 3 inch by 3 inch white box.

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

Source: FDA
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“Company name: Ardil Commercial
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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
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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
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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
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Scam, Phoenix, AZ, USA

Phoenix, AZ, USA

June 28, 2021 11:46 PM

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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
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