Rapid Alert
| SPURIOUS TERBIDERM FORTE TABLET (TERBINAFINE 250 mg) & GLANTRIM OPHTHALMIC SOLUTION |
| DRAP Alert No | No I/S/04-26-18 |
| Action Date | 14 April, 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Atco Laboratories Limited, Karachi has intimated identification of suspected spurious batches of its registered products, namely Terbiderm Forte Tablet (Terbinafine 250 mg) and Glantrim Ophthalmic Solution, during market surveillance. Analytical testing conducted by the manufacturer’s Quality Control Laboratory confirmed that the Active Pharmaceutical Ingredient (API) content was not present in the tested samples. Comparative evaluation with retained samples further revealed significant discrepancies in packaging, labeling, and physical characteristics. Based on these findings, the following batches of these drug products have been found to be Spurious. |
| S # | Name of Product | Batch | Purported to be Manufactured by | Remarks |
| 1 | Terbiderm Forte Tablet (Terbinafine 250 mg) (Reg # 053367) | HH003L | M/s Atco Laboratories Limited, Karachi. B-18 S.I.T.E Karachi. (DML # 000188) | Spurious |
| 2 | Glantrim Ophthalmic Solution Timolol (as Maleate) …. 0.5%w/v Dorzolamide (As HCl) ……2%w/v (Reg # 050622) | LZ010K | Spurious |
| Risk Statement | Terbinafine is indicated for treatment of fungal infections, while Glantrim Ophthalmic Solution is used in management of glaucoma and ocular hypertension. Laboratory findings confirm absence of active ingredients, resulting in complete therapeutic failure. Use of the mentioned batches of these drug products may lead to disease progression, treatment failure, and serious complications, particularly risk of vision-related complications in case of ophthalmic product. The public health risk is assessed as high. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers | Consumers should not use the mentioned batches of these drug products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |