- Counterfeit batches of drugs include Pentrexyl, Broncho-Vaxom, Alka Seltzer, and Sedalmerck.
- Upon identifying them, immediate suspension of supply and marketing is recommended.
- The sale of illegal drugs represents a risk to the health of patients because they could be made with contaminated or toxic substances.
One of the functions of the Federal Commission for the Protection against Sanitary Risks (Cofepris) is the constant monitoring of products and services that could represent a risk to health. With this in mind, a report identified the existence of several batches of counterfeit drugs, including Alka Seltzer and Sedalmerck.
In total they are four the apocryphal drugs. The first of them is Pentrexyl (ampicillin) 500 mg, with lot number 19E623 and expiration date May 2024, in box presentation with 28 capsules. The company Aspen MĂ©xico reported to this authority that said lot number had an original expiration date in May 2021.
In addition, it is observed that the counterfeit product presents, on the back of the secondary packaging, illegible texts covered by a wide colored band. Likewise, it was detected that the content specifications do not correspond to the original product.
Cofepris issues alert on counterfeiting of four medicines: Pentrexyl, Broncho-Vaxom, Alka Seltzer and Sedalmerck. #CofeprisProtects You
👉https://t.co/huprenDfev pic.twitter.com/x7UP1VOkWL
— COFEPRIS (@COFEPRIS) May 28, 2023
The second counterfeit drug is Broncho-Vaxom (standardized lyophilized bacterial lysates) in a presentation of 10 7-mg capsules for adults; with lot numbers 2000172 and 1600021both in secondary packaging, and M141E01 in primary packaging.
In this regard, the company GrĂĽnenthal de MĂ©xico specified the characteristics to identify the irregular drug with lot 2000172, it shows the expiration date of August 2024, while lot 1600021 had an original expiration date of March 2020 in its secondary packaging.
As far as secondary packaging is concerned, they show graphics that are already discontinued and the manufacturer, importer and distributor information is not up to date. Likewise, the company reported that the product with lot number M141E01 was stolen in 2014.
Sanitary alert for counterfeit batches of Alka Seltzer
The third counterfeit drug is Alka Seltzer 100+10 effervescent TABs (sodium bicarbonate/citric acid/acetylsalicylic acid), in presentation of 100 tablets plus 10 tablets, with lot number X235XU and expiration date December 2023; however, the original expiration is September 2020.
Bayer de México reported that this product presents differences with respect to the original box, such as more intense colors in the illustration of the bubbles, and the text “BOX WITH 100 TABLETS” located on the cutting line.
The latest counterfeit product is Sedalmerck (500mg paracetamol, 50mg caffeine and 5mg phenylephrine) in a cardboard box with 200 tablets. The irregular batches are M649565, M90473, M74256, GS4889, and M12003.
Among the elements that make it possible to detect the counterfeit product, it stands out that the registered trademark symbol on the front of the box is very close to the fold line, while on the back it does not have manufacturer and distributor legends. Likewise, the secondary packaging has the legend “Tablets”, but does not indicate the quantity of these it contains.
All counterfeit medicines pose a health risk
The commercialization of irregular drugs —such as counterfeit drugs, without sanitary registration, fractionated, expired, adulterated, and those that are exclusively distributed by the public sector— represents a risk to the health of patients, since they could be made with contaminated substances. , toxic and in other cases, they could have lost their effectiveness due to improper storage.
Due to the above, this federal commission recommends not purchasing medicines in informal establishments and businesses, since they present a health risk by not knowing the quality of their ingredients, their safety in production and correct storage.
Distributors and pharmacies are also urged to review, if they have these products in stock, that they do not have the characteristics described above to rule out that they are counterfeit medicines.
Also read:
Cofepris authorizes 11 new drugs: They work from lung cancer to psoriasis
Miracle! Cofepris authorizes the first clinical trial of a drug against MPOX (monkey smallpox)
Cofepris warns against counterfeit condoms: This is how you can identify them