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GlaxoSmithKline
Updated: June 18, 2020 11:00 PM
GSK Consumer Healthcare Cough and cold products - recalled due to Incorrect dosing cups, USA
1 year ago
Company name: GSK Consumer Healthcare
Brand name: Robitussin
Product recalled: Cough and cold products
Reason of the recall: Incorrect dosing cups
FDA Recall date: June 18, 2020
Recall details: GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children's Robitussin® Honey... See More Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children's Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children's Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.
There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use). Children's Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children's Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults.
Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behaviour; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention.
As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product. The recall is limited to the three lots listed below:
Children's Robitussin® Honey Cough and Chest Congestion DM (4oz)
NDC 0031-8760-12
Lots: 02177 (Exp. Jan. 2022) / 02178 (Exp. Jan. 2022)
Children's Dimetapp® Cold and Cough (8oz)
NDC 0031-2234-19
Lot: CL8292 (Exp. Sep. 2021)
These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Wholesalers, distributors and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately.
Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. In December 2018, GlaxoSmithKline plc reached an agreement with Pfizer, Inc. to combine their consumer health businesses into a new Joint Venture. August 01, 2019 was the first day of the new GSK Consumer Healthcare Joint Venture. Thus, when identifying impacted product, please be aware the Pfizer company name will still be present on the label.
Check the full recall details on fda.gov
Source: FDA See Less
97
Recent Interesting Reports
Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level. Coppertone has identified the presence of benzene in these lots of products Twelve lots of... See More Coppertone spray products are impacted by this voluntary recall, specifically:
- Product Description: CT P&S BABY SPF50 SPRAY 5OZ 12S . Lot: TN0083J UPC: 72140028817. Manufacturing Date: 44470.
- Product Description: CT P&S BABY SPF50 SPRAY 5OZ 12S . TN0083J: TN0083K 72140028817: 72140028817. Manufacturing Date: 44501.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN0083K: TN00854 72140028817: 72140028824. Manufacturing Date: 44531.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN00854: TN00855 72140028824: 72140028824. Manufacturing Date: 1/14/2021.
- Product Description: CT SPORT MIN SPF50 SPRAY 5OZ 12S . TN00855: TN008KU 72140028824: 72140028701. Manufacturing Date: 3/15/2021.
- Product Description: CT SPORT MIN SPF50 SPRAY 5OZ 12S . TN008KU: TN008KV 72140028701: 72140028701. Manufacturing Date: 3/16/2021.
- Product Description: CT P&S SPF50 SPRAY 5OZ 12S . TN008KV: TN00BR2 72140028701: 72140028800. Manufacturing Date: 3/31/2021.
- Product Description: CT P&S BABY SPF50 SPRAY 5OZ 12S . TN00BR2: TN009GH 72140028800: 72140028817. Manufacturing Date: 3/31/2021.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN009GH: TN00857 72140028817: 72140028824. Manufacturing Date: 44351.
- Product Description: CT SPORT SPRAY SPF50 1.6OZ 24S . TN00857: TN00BU3 72140028824: 41100005069. Manufacturing Date: 44352.
- Product Description: CT P&S SPF50 SPRAY 5OZ 12S . TN00BU3: TN00CJ4 41100005069: 72140028800. Manufacturing Date: 6/15/2021.
- Product Description: CT P&S KIDS SPF50 SPRAY 5OZ 12S . TN00CJ4: TN00CJV 72140028800: 72140028824. Manufacturing Date: 6/15/2021.
Benzene is classified as a human carcinogen. Exposure to benzene can occur through inhalation, oral, and skin and it could, depending on the level and extent of exposure, result in an increased risk of cancers including leukemia, and blood cancer of the bone marrow and other blood disorders which can be life-threatening.
Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies.
Out of an abundance of caution, we are recalling certain lots of these specific aerosol sunscreen spray products. To date, Coppertone has not received any reports of adverse events related to this recall.
The voluntarily recalled sunscreen spray products are packaged in aerosol cans. The products were distributed nationally in the United States through various retailers. Consumers should stop using these specific Coppertone aerosol sunscreen spray products and dispose of them appropriately.
Coppertone is also notifying its retailers by letter and is arranging for returns of all voluntarily recalled lots of sunscreen spray products. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these aerosol sunscreen spray products.
The FDA and other medical authorities recognize the public health benefits of sunscreens and strongly advise the use of sunscreen along with other protective measures from the sun.
Company name: Coppertone, owned by Beiersdorf
Brand name: Coppertone
Product recalled: Coppertone aerosol sunscreen spray products
Reason of the recall: Presence of benzene
FDA Recall date: September 30, 2021
Check the full recall details on fda.gov
Source: FDA See Less
97
Company name: Cook Medical
Brand name: Cook Medical
Product recalled: Transseptal Needle and Transseptal Needle Catheter
Reason of the recall: Complaints of rust on the products
FDA Recall date: October 19, 2021
Recall details: Bloomington, Ind. — On October 8, 2021, Cook Medical issued a global, voluntary... See More recall of the Transseptal Needle and the Transseptal Needle with Catheter. This recall includes all unexpired lots for both of these products. The needles were recalled due to complaints of rust on the products. Use of affected products could result in increased procedural time and inflammatory reactions, including systemic reactions which may lead to permanent impairment or death.
The U.S. Food and Drug Administration (FDA) has not yet classified the recall. Products affected by this recall are:
- Transseptal Needle, INTENDED USE: Intended for transseptal left heart access in both diagnostic and interventional procedures, RPN: TSNC-18-71.0 GPN: G02364 and RPN: TSNC-19-56.0 GPN: G02365, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021
- Transseptal Needle with Catheter, INTENDED USE: Intended to facilitate transseptal entry into the left atrium, RPN: TSN-17-75.0-ENDRYS, GPN: G19261, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021
Transseptal Needles, including Transseptal Needles with Catheters, were found to have rust internally, externally, or both. To date, Cook Medical has received no reports of injury or illness related to this recall. Cook has received four complaints where the presence of rust was identified prior to patient contact. However, please be advised that the presence of rust may go undetected by the user. The FDA and other regulatory agencies around the world have been notified of this action.
Potential adverse events: If an affected product is used, potential negative outcomes include increased procedural time (to obtain a replacement device) and inflammatory reactions ranging from local or self-limited reactions to systemic reactions requiring medical intervention. Systemic reactions could potentially lead to permanent impairment or death.
Check the full recall details on fda.gov
Source: FDA See Less
97
It’s been over 20 days for next-state packages and still have not arrived. See Less
5.1K
Company name: Bryant Ranch Prepack
Brand name: Bryant Ranch Prepack
Product recalled: Methocarbamol 500mg
Reason of the recall: Bottles labeled as Methocarbamol 500mg tablets were found to contain Methocarbamol 750mg tablets.
FDA Recall date: October 19, 2021
Recall details: Burbank, CA, Bryant Ranch Prepack is voluntarily recalling... See More 1 lot of Methocarbamol 500mg, Tablets to the consumer level. The bottles labeled as Methocarbamol 500mg Tablets have been found to contain Methocarbamol 750mg Tablets.
Risk Statement: If a patient takes a 750mg Tablet of Methocarbamol instead of the prescribed 500mg Tablets, it potentially could result in Excessive Central Nervous System depression which may result in nausea, sedation, fainting, falls, seizure, coma, and death. Bryant Ranch Prepack has not received any reports of adverse events related to this recall.
The product is used together with rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions and is packaged in a white round bottle with a red and white label, which reads Methocarbamol 500mg packaged in counts of 30 (NDC:7133517952), 60 (NDC: 7133517954), and 90 (NDC:7133517957) pills. The affected Methocarbamol 500mg lots include the following Lot Number 163935/ Exp. Date 10/22. The product can be identified by red and white label with a yellow border at the top and bottom of the label, top of the label reads “Packaged by Bryant Ranch Prepack”, labels are pictured below. The Methocarbamol 500mg was distributed Nationwide to multiple physician offices.
Bryant Ranch Prepack is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Consumers that have the bottles labeled as Methocarbamol 500mg Tablets which is being recalled should stop using immediately and return to place of purchase and/or contact their physician. Distributors/Physicians should stop distribution and contact Bryant Ranch Prepack to return the product immediately.
Check the full recall details on fda.gov
Source: FDA See Less
97
Shipment was supposed to arrive Friday. Now I received the following message : Your shipment has potentially been delayed due to emergency or other conditions at 6:46 pm on October 17, 2021. | Symptoms: Other See Less
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GR
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Same here. Mine arrived at Teterboro 10/14 @ 3:35 pm. 10/17 update says "Processing Exception, Other Delay Your shipment has potentially been delayed due to emergency or other conditions at 6:50 pm on October 17, 2021."
MI
Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
Product recalled: Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg
Reason of the recall: API batches above the specification limit for the impurity, N-nitrosoirbesartan
FDA Recall date: October 14, 2021
Recall details: Baltimore, Maryland, October 14, 2021:... See More Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan.
Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.
Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in Jan 2021. Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide. Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets USP 75mg, 150mg and 300mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan Tablets on Jan 7, 2021. The recalled lots are included in the link below.
Irbesartan and hydrochlorothiazide tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Irbesartan and hydrochlorothiazide tablet USP, 150mg/12.5mg and 300mg/12.5mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan and HCTZ Tablets on Jan 7, 2021. The recalled lots are included in the link below.
Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots.
Patients taking, Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.
Wholesalers, distributors and retailers that have Irbesartan Tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg that are being recalled should discontinue distribution of the recalled product lots immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 769-3988 / (855) 769-3989.
Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 769-3988 / (855) 769-3989 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the bottle label.
Check the full recall details on fda.gov
Source: FDA See Less
97
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If you have any health, safety, or community issue, including issues with delivery services, report it to SafelyHQ. Reporting will help identify and bring attention to common problems that impact friends, family, and our communities at the local and national level.
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