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RECALL ALERT – DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY, KARACHI.

Ahsan Hafiz Recall Alerts

Recall Alert

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DRAP Alert NoNo II/S/08-25-55
Action Date18 August, 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1.Famila 28F Tablets
Each Tablet contains: Levonorgestrel…0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K185M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol) and Assay(Levonorgestrel).
2.Famila 28F Tablets
Each Tablet contains: Levonorgestrel…..0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K189M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol) and Assay (Levonorgestrel).
3.Famila 28F Tablets
Each Tablet contains: Levonorgestrel……0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K187M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)  		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), Weight variation of Ferrous Iron and Assay (Levonorgestrel & Ethinyl Estradiol).  
4.Famila 28F Tablets
Each Tablet contains: Levonorgestrel……0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K192M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)  		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel & Ethinyl Estradiol).  
5.Famila 28F Tablets
Each Tablet contains: Levonorgestrel……0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K194M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)  		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel).  
6.Famila 28F Tablets
Each Tablet contains: Levonorgestrel……0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K195M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)  		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel).  
    7.Imcomox 125mg/5ml Suspension Each 5ml of reconstituted suspension contains: Amoxicillin (as Trihydrate) ………………….125mg (Reg. No. 013756)029M/s. Imco Pharmaceutical Lab.
73/A Industrial Estate Jamrud Road, Peshawar
(DML#000317)		‘Substandard’ on the basis of Assay (Amoxicillin trihydrate).  
8.Imcodal Oral Suspension
Each 5ml of Suspension contains: Metronidazole Benzoate.. 64mg
Ethinyl Furazolidone….25mg
(Reg. No. 013363)		013M/s. Imco Pharmaceutical Lab.
73/A Industrial Estate Jamrud Road, Peshawar
(DML#000317)		‘Substandard’ on the basis of Assay (Furazolidone).
Risk Statement:Famila 28F: The affected batches of Famila 28F Tablets due to content uniformity, assay failures of hormonal ingredients, and weight variation in the iron component, may lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation, increasing the risk of complications, particularly in vulnerable groups such as Young Women, Perimenopausal Women, Women with history of Anemia, Patients with Comorbidities.

Imcomox: Laboratory testing has confirmed that the amoxicillin content in this drug product is below the approved specification range, making it subpotent. Such reduced strength may cause treatment failure, particularly in infants and young children, the primary users of this medicine. The recall is being undertaken to prevent potential health risks and safeguard public safety.

Imcodal: Laboratory testing has confirmed that the furazolidone content in this suspension is below the approved specification range, indicating subpotency. Inadequate active ingredient may lead to ineffective treatment of gastrointestinal infections, particularly in children, who are the primary recipients of this medicine. This recall is being carried out to prevent treatment failure and protect public health.
Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.

– All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company.

–Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk.

–Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.