Recall Alert
| DRAP Alert No | No I/S/11-23-44 |
| Action Date | 21st Dec, 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 informed DRAP regarding the sample of product namely “Espezar tablet” Batch No. A401 manufactured by M/s. Avant Pharmaceuticals (Pvt.) Ltd., Plot No. 28 Hub Industrial Estate, Hub Balochistan has been declared as of “Substandard” quality. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Espezar 20mg Tablets Reg.No 102983 | Esomeprazole | Batch No. A401 Mfg. Date: 11-22 Exp. date: 11-24 | M/s Avant Pharmaceutical Pvt. Ltd, Hub, Baluchistan |
| Risk Statement: | Esomeprazole is used to treat certain stomach and oesophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid the stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). Impact of use of substandard product may leads to sub optimal therapeutic effect which may cause therapy failure or other associated problems. |
| 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. |