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Rompe Pecho Liquid Cold and Flu - recalled due to microbial contamination, United States

2 years ago source www.fda.gov

Recall notice

United States

Efficient Laboratories is expanding its voluntary nationwide recall to consumers to include an additional twelve lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM due to microbial contamination concerns. These lots were distributed in 2019.

To date, Efficient Laboratories has not received any reports of adverse events. In rare circumstances, consumption of these specific lots could result in illness. These products are used to treat symptoms of the flu and the common cold, and each are packaged in a box containing a bottle of the liquid product.

The affected twelve lots of Rompe Pecho product are contained in the list below:

Rompe Pecho CF
Lots: 19F88 (Exp. Jun. 2022)
19G164 (Exp. Jul. 2022)

Rompe Pecho DM
Lots: 19F168 (Exp. Jun. 2022),
19G145 (Exp. Jul. 2022), 19G361 (Exp. Jul. 2022), 19G449 (Exp. Jul. 2022),
19G491 (Exp. Jul. 2022)

Rompe Pecho EX
Lots: 19H20 (Exp. Aug. 2022), 19J98 (Exp. Sep. 2022), 19A418 (Exp. Jan. 2022),
19E411 (Exp. May 2022)

Rompe Pecho MAX
Lot: 19G219 (Exp. Jul. 2022)

Company name: Efficient Laboratories, Inc
Brand name: Rompe Pecho
Product recalled: Liquid Cold and Flu symptom relief
Reason of the recall: Microbial contamination
FDA Recall date: December 10, 2021

The lot numbers and expiration dates can be found on the bottom of the cartons. These Rompe Pecho products were distributed nationwide to wholesalers and retailers.

Consumers that have Rompe Pecho EX, Rompe Pecho CF, Rompe Pecho DM, or Rompe Pecho MAX from these lots that are being recalled should stop using these products and discard them. Efficient Laboratories has notified its distributors of these lots. All distributors have confirmed there is no product in their inventory. In addition, a review of certain stores confirmed no inventory at the retail level as well.

Check the full recall details on www.fda.gov

Source: FDA

#drugs #recall #us

Recent Interesting Reports

Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel to the consumer level. The products have been found to contain alcohol denatured with methanol. Products were distributed between 5/1/2021 and 10/27/2023 and sold in … See More
the US online only via the Aruba Aloe Balm N.V. website. To date, Aruba Aloe Balm N.V. has not received any reports of adverse events related to these products.

Aruba Aloe Hand Sanitizer Gel is used as a sanitizer to help reduce bacteria that potentially can cause disease and is packaged in 12 fl oz (355 mL) dark green plastic bottles with white label reading in part “ARUBA ALOE Hand Sanitizer GEL 80% Alcohol Made in Aruba World’s Finest Aloe”, with barcode 0 82252 03300 5.

Aruba Aloe Alcoholada Gel is used for temporary relief of pain and itching associated with minor burns, sunburn, insect bites, or minor skin irritations and is packaged in two sizes: 2.2 fl oz (65 mL) plastic bottles with barcode 0 82252 34030 1 and 8.5 fl oz (251 mL) plastic bottles with barcode 0 82252 03120 9. The plastic bottles are transparent with a label reading in part “Alcoholada Gel Pain Relieving Gel 0.5% Lidocaine Hydrochloride”.

The affected Aruba Aloe Hand Sanitizer GEL product lots (filled in 12, 2.2, and 8.5 fl. oz bottles bottles) can be viewed in the link below.

Aruba Aloe Balm N.V. has notified all customers that bought these products by email and has offered a discount coupon for a next purchase. Consumers that have products which are being recalled should stop using and discard the product.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache blurred vision, coma, seizures, permanent blindness, permanent damage to the central 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.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Aruba Aloe Balm N.V.
Brand name: Aruba Aloe
Product recalled: Hand Sanitizer Gel and Alcoholada Gel
Reason of the recall: Product contains methanol
FDA Recall date: April 05, 2024

Source: www.fda.gov
See Less

#recall #us

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