Recall Alert
| DRAP Alert No | No II/S/09-23-38 |
| Action Date | 16th Oct, 2023 |
| Target Audience | · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public |
| Problem / Issue | Federal Government Analyst, CDL Karachi has declared the Batch No. L083 of product “Kemodryl Cough Syrup” as of substandard quality. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Kemodryl Cough Syrup Reg.No 007069 | Chlorpheniramine Maleate 4mg: Ammonium Chloride 125mg : Sodium Citrate 55mg | Batch No K-1068 Mfg. Date: Aug 2023 Exp. Date: July 2025 | Ms. Alkemy Pharmaceutical Laboratories (Pvt) Ltd., Hyderabad. |
| Risk Statement: | Kemodryl Cough Syrup is a combination of Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate which relieves cough. Chlorpheniramine is an anti-allergic which relieves allergy symptoms like runny nose, watery eyes and sneezing. Ammonium chloride can be used as an expectorant due to its irritative action on the bronchial mucosa. Sodium citrate is a mucolytic. Inaccurate use of the product may lead to common side effects like Stomach pain/epigastric pain, Allergic reaction, sleepiness, thickened respiratory tract secretions and impaired coordination. The impact of the use of substandard products on the basis of a higher limit of assay tests may cause adverse reactions on therapeutic doses. |
| Action Initiated | -The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -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 through phone at +92 51 910 73 17, 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 Professionals | DRAP 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 this 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. |