Nationwide recall of fake Theophylline 100mg asthma treatment drug

The Drug Administration has just announced a counterfeit drug Theophyllin extended-release tablet (Theophylline 100mg). This is a drug used in cases of asthma and some other respiratory diseases.

Counterfeit drugs contain less than 20% of the standard amount of substances.

The Drug Administration of Vietnam (Ministry of Health) has just issued Official Dispatch No. 2057/QLD-CL dated July 22, 2025 requesting the Department of Health of Dong Nai province to urgently report to Steering Committee 389 and coordinate with relevant authorities to inspect and examine My Anh General Clinic Company Limited, located in Bu Gia Map District, Binh Phuoc Province (old).

At the same time, trace the origin of the product batch with the information on the label: Theophyllin extended - release tablet (Theophylline 100mg); place of manufacture: Pharmacy Laboratories Plus. The product label does not have information about: circulation registration certificate, import license number, or import facility.

The batch of fake Theophyllin medicine with a substance content of less than 20% was requested to be recalled nationwide and stopped being used.

PHOTO: DAV.GOV.VN

Previously, the Drug Administration Department received a report from the Dong Nai Provincial Testing Center that the product sample with the information on the label: Theophylline extended - release tablets 100mg (Theophyllin 100mg), batch number 05089, production date 2.3.2022, expiration date 2.3.2026; manufacturing place Pharmacy Laboratories plus (Warszawa) did not meet the quality requirements for quantitative indicators (19.71% Theophylline according to Vietnamese Pharmacopoeia standards).

The drug sample was taken by the Interdisciplinary Inspection Team of Dong Nai province (formerly Binh Phuoc) at My Anh General Clinic Company Limited (My Anh pharmacy, in Bu Gia Map district, former Binh Phuoc province).

The Drug Administration of Vietnam requests the provincial and municipal health departments to notify drug trading and usage establishments and people not to buy, sell, or use the above-mentioned Theophyllin extended-release tablet; and promptly report any suspicious signs of production and trading of counterfeit drugs or drugs of unknown origin to health agencies and relevant authorities.

According to information from the treatment unit, Theophylline 100mg has a bronchodilator effect and is often used to prevent and treat wheezing, control asthma symptoms, chronic bronchitis...

Revocation of registration for circulation of drugs violating quality

Also in July, the Drug Administration of Vietnam decided to revoke the drug circulation registration certificate in Vietnam for the drug Femancia, registration number: VD-27929-17, from the list of drugs granted a circulation registration certificate in Vietnam, according to the provisions of Point b, Clause 1, Article 58 of the Law on Pharmacy (within 60 months, 2 drug batches are forced to be recalled due to violations at level 2; or 3 or more drug batches violate quality). Drugs with revoked registration numbers cannot be produced and circulated on the market from July 16, 2025.

At the same time, the Drug Administration also announced a mandatory recall to all pharmaceutical businesses, medical examination and treatment facilities and users of the above batches of Femancia medicine with registration number: VD-27929-17, due to level 2 violations.

Source: https://thanhnien.vn/thu-hoi-toan-quoc-thuoc-gia-theophylline-100mg-dieu-tri-hen-185250723100322153.htm