GSK Children’s Dimetapp & Robitussin Recall [US]


GSK Dimetapp & Robitussin Recall [US]

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US FlagUS/Silver Spring: GSK Consumer Healthcare, a Warren, New Jersey establishment, recalls two batch/lots of Children’s Robitussin Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp Cold and Cough from the American marketplace due to suspected inclusion of incorrect dosing cups and consequential risks of medication overdose and/or medication under-dosage, all serious health hazards.

FDA: http://ht.ly/bC3e30qRUAQ

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gsk-consumer-healthcare-issues-voluntary-nationwide-recall-childrens-robitussinr-honey-cough-and

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Children’s medications are subject to this recall:

  • Children’s Dimetapp Cold and Cough, sold in 8-ounce bottles with a batch/lot of CL8292, an expiry date of September 2021 and an NDC of 0031-2234-19
  • Children’s Robitussin Honey Cough and Chest Congestion DM, sold in 4-ounce bottles with a batch/lot of 02177, an expiry date of January 2022 and an NDC of 0031-8760-12
  • Children’s Robitussin Honey Cough and Chest Congestion DM, sold in 4-ounce bottles with a batch/lot of 02178, an expiry date of January 2022 and an NDC of 0031-8760-12

Please consult the photograph above for details of the food’s packaging, design and retail presentation. Additional image/images of the recalled children’s medications can be found on the Web site above.

==> No barcodes, DINs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

According to the FDA, during the review of the packaging documents for these products, GSK discovered the dosing cups for the Children’s Robitussin Honey products 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.

Although the medications themselves are reportedly safe to consume, the problem is with the dosing cup.

The recalled batch/lots were distributed US 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 medications. Wholesalers, distributors and retailers with an existing inventory of the batch/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.

Symptoms of overdose of either medication 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 behavior; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention.

For physicians, poison control and other medical personnel, these medications are composed of the following:

  • 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.
  • 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.

==> Never depend on your senses of sight, smell, taste or touch to confirm food poisoning, adulteration or contamination. If in doubt about the safety of any food, return it to your retailer for refund or toss it out in your household garbage, making sure neither small children nor household pets can access the suspect food.

If you believe you have purchased or have in your possession any of the recalled Children’s Robitussin and/or Children’s Dimetapp, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the medication to the store where you purchased it for a full refund.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to properly treat poisonings.

==> To see other recalls and notifications caused by contaminated, adulterated or mislabeled medications, please search for “drug” using the Search Box at the top of this page.

If you have any further questions, comments or complaints about this recall, please contact the company at GSK Consumer Healthcare at 1-800-762-4675 from 8:00 AM to 6:00 PM Eastern Standard Time, Monday to Friday.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by GSK Consumer Healthcare, please search for “GSK” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Dimetapp brand name, please search for “Dimetapp” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Robitussin brand name, please search for “Robitussin” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 13161-2020
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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