DRAP Issues Drug Safety Alerts for Rhophylac 300, Tobramycin, Modafinil and Other spurious and unregistered Therapeutic Products in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) has issued three rapid alerts between November 2 and November 5, 2026, concerning  adulterated, substandard, spurious and unregistered therapeutic products. The alerts cover Rhophylac 300 Injection, Tobramycin Ophthalmic Solution, Flecainide Acetate 50mg, Modafinil 200mg, Mysoline 250mg, and several other medicines and healthcare products. Consumers and healthcare professionals are advised to take note of the identified products, batch numbers, manufacturers, and associated safety risks.

1. Spurious/Falsified Rhophylac 300 Injection – Batch No. P100830101

DRAP Alert No.: No. I/S/11-02-49
Alert Date: November 2, 2026
Product Status: Spurious/Falsified

DRAP has issued a rapid alert regarding a falsified batch of Rhophylac 300 Injection after receiving confirmation from its Marketing Authorization Holder (MAH), M/S Hakimsons (Impex) (Pvt.) Ltd., Karachi.

Therapeutic Product Information:

• Product Name: Rhophylac 300 Injection.

• Dosage Form: Solution for injection in a pre-filled syringe.

• Batch Number: P100830101.

• Purported Manufacturer: M/s CSL Behring AG, Switzerland.

• Marketing Authorization Holder: M/S Hakimsons (Impex) (Pvt.) Ltd., Karachi.

• Alert Classification: Spurious/Falsified.

Reason for the Alert:

• The MAH confirmed that batch P100830101 is not associated with its company.

• The batch does not belong to the company’s authorized product distribution.

• The product has therefore been classified as spurious under Section 3(z)(b)(ii) of the Drugs Act, 1976.

Potential Health Risks:

• The falsified product may fail to produce the intended therapeutic response.

• Its use may expose recipients to unknown safety risks.

• It may raise serious concerns regarding product quality and public health.

2. Adulterated, Substandard, Spurious and Unregistered Drug Products – DTL Sindh, Karachi

DRAP Alert No.: No. I/S/11-05-50
Alert Date: November 5, 2026
Product Status: Adulterated/Substandard/Spurious/Unregistered

DRAP has reported nine drug products declared adulterated, substandard, spurious, and unregistered by the Drug Testing Laboratory (DTL), Sindh, Karachi.

Identified Adulterated, substandard, spurious & unregistered Therapeutic Products:

1. Baby Eye Spray

   • Active Ingredient: Tobramycin.

   • Batch Number: Not mentioned.

   • Manufacturer: LC Care Pharma, Karachi Industrial Area, Block B, Suite #4.

   • DTL Classification: Adulterated, substandard, spurious, and unregistered.

2. Tobramycin Ophthalmic Solution

   • Active Ingredient: Tobramycin.

   • Batch Number: Not mentioned.

   • Manufacturer: LC Care Pharma, Karachi Industrial Area, Block B, Suite #4.

   • DTL Classification: Adulterated, substandard, spurious, and unregistered.

3. Total Care Mouthwash

   • Active Ingredients: Benzydamine and Chlorhexidine.

   • Batch Number: Not mentioned.

   • Manufacturer: LC Care Pharma, Karachi Industrial Area, Block B, Suite #4.

   • DTL Classification: Adulterated, substandard, spurious, and unregistered.

4. Magic Lotion

   • Active Ingredient: Calamine.

   • Batch Number: 002.

   • Manufacturer: LC Care Pharma, Karachi Industrial Area, Block B, Suite #4.

   • DTL Classification: Adulterated, substandard, spurious, and unregistered.

5. Denzicor Mouth Wash

   • Active Ingredients: Benzydamine and Chlorhexidine.

   • Batch Number: Not mentioned.

   • Manufacturer: LC Care Pharma, Karachi Industrial Area, Block B, Suite #4.

   • DTL Classification: Adulterated, substandard, spurious, and unregistered.

6. Anti Plaque Mouth Wash

   • Active Ingredient: Chlorhexidine.

   • Batch Number: Not mentioned.

   • Manufacturer: LC Care Pharma, Karachi Industrial Area, Block B, Suite #4.

   • DTL Classification: Adulterated, spurious, and unregistered.

7. Happy Tooth Kids Mouthwash

   • Active Ingredient: Chlorhexidine.

   • Batch Number: Not mentioned.

   • Manufacturer: LC Care Pharma, Karachi Industrial Area, Block B, Suite #4.

   • DTL Classification: Adulterated, spurious, and unregistered.

8. Baby Care Ear Cream

   • Active Ingredient: Lidocaine.

   • Batch Number: Not mentioned.

   • Manufacturer: New Herbal Care, Karachi Industrial Area, Clifton Block 17, Commercial Area Street.

   • DTL Classification: Adulterated, substandard, spurious, and unregistered.

9. Vital Ear Cream

   • Active Ingredient: Lidocaine.

   • Batch Number: Not mentioned.

   • Manufacturer: New Herbal Care, Karachi Industrial Area, Clifton Block 17, Commercial Area Street.

   • DTL Classification: Adulterated, substandard, spurious, and unregistered.

Potential Health Risks:

• Use of these products may result in therapeutic failure.

• Consumers may experience adverse health consequences.

• The products may expose users to unknown safety and quality risks.

3. Unregistered Drug Products Identified by Central Drugs Laboratory, Karachi

DRAP Alert No.: No. I/S/11-05-51
Alert Date: November 5, 2026
Product Status: Unregistered

The Central Drugs Laboratory (CDL), Karachi, has declared three drug products unregistered following laboratory assessment.

Identified Therapeutic Products:

1. Flecainide Acetate 50mg Tablet

   • Strength: 50mg.

   • Batch Number: FDAG020.

   • Manufacturer: Brown & Burk UK Ltd., UK.

   • CDL Classification: Unregistered.

2. Modafinil 200mg Tablet

   • Strength: 200mg.

   • Batch Number: MDSB25008A.

   • Manufacturer: Milpharm Limited, UK.

   • CDL Classification: Unregistered.

3. Mysoline 250mg Tablet (Compresse/Tablet)

   • Strength: 250mg.

   • Batch Number: 4626.

   • Manufacturer: Laboratorio Farmaceutico SIT S.r.l., Via Cavour, 70-27035 Mede (PV).

   • CDL Classification: Unregistered.

Potential Health Risks:

• The use of these unregistered medicines may create serious public health and safety concerns.

• Their administration may lead to therapeutic failure.

• Consumers may face adverse health consequences or unknown safety risks.