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GlaxoSmithKline
Updated: June 18, 2020 11:00 PM
USGSK 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
413
Recent Interesting Reports
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I have had two packages that have 'gone missing' with USPS and have now had to refund customers. The packages never seem to leave NJ and both contained the same single items (a CD). The first small media mail package was sent on March 15th, 2022 -->... See More Departed post office in Pitman, NJ on Mar 15 --> arrived at South Jersey NJ Distribution Center March 15 @ 3:54pm --> March 19th - In transit to next facility and no updates after that. During April: spent a few calls completing the 'missing mail' forms both electronically and speaking to 'investigators' who promise to call back. When I receive call-backs it's to say that my missing mail electronic form 'wasn't fully filled out' or that 'the missing report action has not been updated' or that they are 'now pushing it forward.' No notifications from the USPS since then. My second package that I am going to have to refund the customer for was another small media mail package with CD sent April 25th 2022 --> USPS in possession from Sewell NJ --> April 25 2022 Departed Post Office Sewell NJ --> April 29 2022 "In transit, arriving late". It is now May 17th and still no package to the customer. See Less
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Pfizer Accupril (Quinapril HCl) tablets - recalled due to Due to N-Nitroso-Quinapril, USA
4 weeks ago
Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.
Nitrosamines are common in water and foods, including... See More 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.i Accupril is indicated for the treatment of hypertension, to lower blood pressure.
Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.
The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. Accupril® (Quinapril HCl Tablets), 10 mgAccupril® (Quinapril HCl Tablets), 20 mgAccupril® (Quinapril HCl Tablets), 40 mg.
NDC: 0071-0530-23
Lot Number: DR9639
Expiration Date: 2023 MAR 31
Strength: 10 mg
Configuration/ Count: 1 x 90 count bottle
NDC: 0071-0532-23
Lot Number: DX8682
Expiration Date: 2023 MAR 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle
NDC: 0071-0532-23
Lot Number: DG1188
Expiration Date: 2022 MAY 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle
NDC: 0071-0535-23
Lot Number: DX6031
Expiration Date: 2023 MAR 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle
NDC: 0071-0535-23
Lot Number: CK6260
Expiration Date: 2022 MAY 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle
Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.
Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.
If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you.
If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you.
Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product.
Company name: Pfizer
Brand name: Pfizer
Product recalled: Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg
Reason of the recall: Due to N-Nitroso-Quinapril Content
FDA Recall date: April 22, 2022
Source: fda.gov See Less
414
Alpine Fresh, Inc. of Doral, Florida is voluntarily recalling its 1 pound packages of "Hippie Organics" French Beans from lot# 313-626, because they have the potential to be contaminated with Listeria monocytogenes. The recalled "Hippie Organics 1lbs French Beans" were distributed in Whole Foods (CT, FL, GA,... See More IL, MD) , Aldi (FL) and LIDL (DE, GA, MD, NJ, NY, NC, PA, SC, VA) retail stores.
Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
The product comes in a 1 pound, clear plastic package marked with lot # 313-626 on the back on a small, white label. No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after routine testing by the company revealed the presence of Listeria monocytogenes in 1 pound packages of "Hippie Organics French Beans From lot # 313-626." The problem has been found to be isolated to the identified lot and the company has taken corrective actions to prevent a recurrence. Consumers who have purchased 1 pound packages of "Hippie Organics French Beans from lot #313-626" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-866-827-3362.
Company name: Alpine Fresh, Inc.
Brand name: Hippie Organics
Product recalled: French Beans
Reason of the recall: Listeria monocytogenes contamination
FDA Recall date: April 21, 2022
Source: fda.gov See Less
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amazon.com
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St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli.
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Affected products:
Lot: A67185
Item number: 805359
Size: 500 mL
NDC number: 51552-1123-5
Expiration date: 08/31/2024
Lot: A67186
Item number: 802496
Size: 4 L
NDC number:51551-1123-9
Expiration date: 08/31/2024
Fagron has already notified its distributors and customers by phone, e-mail, and/or letter and is arranging for return of all recalled products. Hospitals, pharmacies, and distributors that possess affected product should quarantine this material and await further instructions from Fagron or Fagron’s recall coordinator. Please immediately discontinue use or distribution of the recalled product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company name: Fagron Inc.
Brand name: Fagron
Product recalled: SyrSpend SF 500mL and 4L
Reason of the recall: Potential contamination with Burkholderia gladioli
FDA Recall date: May 02, 2022
Source: fda.gov See Less
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