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Sheetz #580, 4651 Lindle Rd, Harrisburg, PA 17111, USA
Total all time reports:
1
Latest report: April 19, 2020 12:00 PM
More incidents from:
Cafe
Convenience store
Gas station
Restaurant
Coronavirus - Covid-19
4651, Lindle Road
Harrisburg
Pennsylvania
United States
Convenience stores employee tests positive for COVID-19
April 19, 2020 12:00 PM
“A Sheetz employee has tested positive for COVID-19 at the Harrisburg store located at 4651 Lindle Road.
Source: local21news.com See Less ”
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July 7, 2020 3:00 PM
“Company name: Mylan Institutional LLC
Brand name: Mylan
Product recalled: Daptomycin for Injection
Reason of the recall: Presence of particulate matter
FDA Recall date: July 07, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is ... See Moreconducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall.
Intravenous administration of a solution containing visible particulates could lead to serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. This batch was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020. The recalled batch is as follows:
- NDC #: 67457-813-50
- Material Description: Daptomycin for Injection
- Strength: 500 mg/vial
- Size: 20 mL vial
- Lot No: 7605112
- Expiry: October 2021
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This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
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June 5, 2020 4:00 PM
“Company name: Teva Pharmaceuticals USA Inc.
Brand name: Actavis
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 05, 2020
Recall details: Teva Pharmaceuticals U ... See MoreSA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). 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 is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.
The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.
- NDC: 62037-571-01/ Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1329548A/ Expiration: 06/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1338302M/ Expiration: 10/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348968M/ Expiration: 10/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348969M/ Expiration: 11/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348970M/ Expiration: 10/2020
- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1376339M/ Expiration: 09/2021
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1323460M/ Expiration: 06/2020
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1330919M/ Expiration: 06/2020
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1338300A/ Expiration: 10/2020
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1341135M/ Expiration: 12/2020
- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1391828M/ Expiration: 11/2021
- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333338M/ Expiration: 08/2020
- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333339A/ Expiration: 08/2020
- NDC: 62037-577-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count/ Lot Number: 1354471A/ Expiration: 02/2021
Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US 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 See Less ”
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Nizatidine Oral Solution 15 mg/mL - recalled due to NDMA (Nitrosodimethylamine) impurity, Bridgewater, New Jersey, USA
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“Company name: Amneal Pharmaceuticals, LLC
Brand name: Gemini Laboratories
Product recalled: Nizatidine Oral Solution 15 mg/mL
Reason of the recall: NDMA (Nitrosodimethylamine) impurity
FDA Recall date: April 15, 2020
Recall details: Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is volunt ... See Morearily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. 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. Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06598004A. Expiration Date: 04/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599001A. Expiration Date: 12/2020
- NDC: 60846-301-15. Description: Nizatidine Oral Solution. Lot: 06599002A. Expiration Date: 12/2020
The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.
Check the full recall details on fda.gov
Source: FDA See Less ”
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“Company name: ITECH 361
Brand name: All Clean
Product recalled: Hand sanitizer
Reason of the recall: Potential presence of methanol (wood alcohol).
FDA Recall date: July 06, 2020
Recall details: Company Announcement ITECH 361 is voluntarily recalling 18,940 bottles of All Clean Hand Sanitizer, ... See MoreMoisturizer and Disinfectant sold in one liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning To date ITECH 361 has not received reports of adverse events related to this recall. The product is used as a hand sanitizer and moisturizer and is packaged in one (1) liter plastic bottles with UPC Code 628055370130. All Clean Hand Sanitizer and Moisturizer was distributed Nationwide to wholesale distributors and retailers. ITECH 361 is notifying its distributors by a Notice of a voluntary recall and consumers via this press release. ITECH 361 is arranging for return/replacement or refund of all recalled products. Consumers/distributors/retailers that have the product subject to this recall should stop using All Clean Hand Sanitizer, Moisturizer and Disinfectant and return it to the place of purchase. Consumers with questions regarding this recall can contact Corina Enriquez by phone number (888)405-4442 or e-mail at corina@itech361.com, Monday through Friday beginning July 6, 9:00a.m. to 5:00 p.m. (MDT). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this 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
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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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