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136. Rapid Alert – Spurious Tablet EFASTON – Batch # 51062

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Rapid Alert

SPURIOUS (TABLET EFASTON 10mg) – Batch # 51062

DRAP Alert NoNo I/S/01-26-136
Action Date23 January , 2026
Target Audience·         Regulatory Field Force of DRAP and Provincial Drug Control departments.
·         Healthcare Professionals (Gynecologists, Obstetricians, Pharmacists, Drug Distributors, Hospitals, Clinics,)
·         Consumers (General Public)
Problem StatementThe Drug Regulatory Authority of Pakistan has been informed through an official test/analysis report issued by the Drug Testing Laboratory, Government of the Punjab, that a sample of Efaston® (Dydrogesterone) 10 mg film-coated tablets (Reg. # 064835), Batch No. 51062, manufactured by Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd., Lahore (DML # 000064), has been declared SPURIOUS under Section 3(zb)(i) of the Drugs Act, 1976. Laboratory analysis confirmed that the declared active ingredient Dydrogesterone was not identified, and assay results showed 0.0 mg per tablet, despite a labeled strength of 10 mg.

The product identification details are as under: –

Risk StatementEfaston® (Dydrogesterone) is commonly prescribed for gynecological and obstetric indications. Use of a spurious product containing no active ingredient may result in therapeutic failure, leading to serious clinical consequences, including unmanaged hormonal conditions, pregnancy-related complications, and risk to maternal health.
Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product.

·         The product has been declared SPURIOUS under the Drugs Act, 1976.
·         Provincial Drug Control Authorities and DRAP Field Forces have been directed to initiate immediate enforcement action, including market surveillance, seizure, and recall of the affected batch.
·         Further regulatory action is being taken in accordance with applicable laws.
Advice for Healthcare ProfessionalsHealthcare professionals are advised to immediately stop prescribing, dispensing, or using Efaston® (Dydrogesterone) 10 mg, Batch No. 51062. All available stock should be verified to ensure procurement from  authorized sources only, and any suspected presence of the affected batch in the supply chain must be promptly reported to DRAP or the concerned Provincial Drug Control Authorities. In addition, patients who may have received the said product should be appropriately identified, monitored, and managed clinically in accordance with standard medical practice.
Any adverse events or quality problems experienced with the use of these products should be reported to  National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
Advice for ConsumersConsumers are advised not to use Efaston® (Dydrogesterone) 10 mg tablets of Batch No. 51062. If this product is currently being used, patients should immediately consult their healthcare provider for appropriate medical advice and further management. Medicines should only be purchased from licensed pharmacies, and any suspected or doubtful products should be promptly reported to the concerned drug inspectors or to DRAP.

134. Recall Alert (Class-II) – CDL declared substandard – Henafim Paediatric Suspension

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Recall Alert

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DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

DRAP Alert NoNo II/S/01-26-134
Action Date14 January, 2025.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Central Drug Laboratory (CDL) Karachi informed that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatchManufacturersRemarks
1.Henafim Paediatric Suspension
Each 5ml contains: Paracetamol …. 120mg Chlorphineramine Maleate …. 1mg
(Reg. # 078545)		558M/s Wisdom Pharmaceutical Industry. (DML # 000780) 78-A Industrial Estate Hayatabad Peshawar.The samples have been declared  “Sub-Standard” on the basis  of assay test of Paracetamol (71%) & Chlorpheniramine Maleate (81%).
Risk Statement:The use of Henafim Paediatric Suspension, Batch No. 558, poses a potential risk to public health, particularly affecting infants and children, who are the primary users of this product for the management of fever, pain, and allergic symptoms. The product has been declared sub-standard due to low assay results of Paracetamol (71%) and Chlorpheniramine Maleate (81%), which may lead to inadequate therapeutic response, resulting in poor fever control, persistent discomfort, and unresolved allergic symptoms. This may prompt caregivers to administer repeated or higher doses, increasing the risk of medication misuse. Although not adulterated, the reduced potency of this paediatric formulation may compromise effective treatment in a vulnerable population, warranting regulatory attention and appropriate risk management.
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.