Month: November 2023
Minutes of 292nd Meeting of Central Licensing Board held on 04th October 2023
Recall Alert: Drug Product; Piperazine Elixer (Batch # L-085) by Swat Pharmaceuticals, Swat
Recall Alert
| DRAP Alert No | No II/S/10-23-41 |
| Action Date | 20th Nov, 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. L085 of product “Piperazine Elixer” as of substandard quality. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Piperazine 750mg/5ml Elixir Reg.No 002235 | Piperazine Citrate | Batch No L-085 Mfg. Date: June 2023 Exp. Date: May 2025 | Ms. Swat Pharmaceuticals, Saidu Sharif Swat. |
| Risk Statement: | Piperazine Citrate is used to treat common roundworms (ascariasis) and pinworms (enterobiasis; oxyuriasis). To avoid the common side effects of gastrointestinal disturbances, headache, dizziness, and urticaria, it is important to use the product accurately. It is critical to ensure that the product is not substandard, as its use can significantly alter the dose and lead to suboptimal therapeutic effects. |
| 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. |
Minutes of 45th Meeting of Clinical Studies Committee
Recall Alert; Drug Product: Recall of Liquid Preparations for Suspected Contamination of DEG/EG Impurities by M/s Pharmix Laboratories, Lahore
Recall Alert
| DRAP Alert No | No I/S/11-23-40 |
| Action Date | 16th November 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 | DRAP has issued a recall of certain batches of liquid preparations due to suspected contamination with diethylene glycol (DEG) and ethylene glycol (EG). WHO has also informed the suspected presence of DEG/EG impurities in batch No. B220 of Alergo Syrup, (identified in the Maldives) which was manufactured by M/s. Pharmix Laboratories (Pvt.) Ltd., Lahore. Following a preliminary investigation conducted by DRAP Lahore, it is suspected that these impurities may also be present in other batches and products mentioned below. This recall is a precautionary measure taken to safeguard public health against the potential harmful effects of these impurities |
Therapeutic Good(s) Affected: –
| Product Names | Batch No | Manufacturer |
|---|---|---|
| Mucorid Syrup | A230, C227, A211, A212, B201, L111, A210, A230, B224, L121, C210, B201, B225 | M/s. Pharmix Laboratories (Pvt.) Ltd., 21-Km Ferozpur Road, Lahore. |
| Ulcofin Suspension | B209, C223 | -do- |
| Alergo syrup | B220, L126 | do- |
| Emidone Suspension | B227 | do- |
| Zincell Syrup | C218 | do- |
| Risk Statement: | Between 2022 and 2023, several countries reported incidents of oral liquid drugs that were intended for children and were found to be contaminated with high levels of DEG and EG. These incidents lead to severe adverse events and fatalities in few countries. |
| Action Initiated | -The manufacturing company has been directed to immediately recall the defective batches of the above-mentioned products from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to immediately check their stocks and stop supplying these batches of suspected products. The remaining stock 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 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. |
Recall Alert: Drug Product; Weena Syrup (Batch # L-090) by Swat Pharmaceuticals, Swat
Recall Alert
| DRAP Alert No | No II/S/10-23-39 |
| Action Date | 6th Nov, 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. L090 of product “Weena Syrup” as of substandard quality. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Weena Syrup Reg.No 003049 | Ferrous sulfate and ascorbic acid | Batch No L-090 Mfg. Date: May 2023 Exp. Date: Apr 2025 | Ms. Swat Pharmaceuticals, Saidu Sharif Swat. |
| Risk Statement: | Ferrous sulphate and ascorbic acid are used to treat and prevent iron deficiency anemia, as well as in prophylaxis for iron deficiency. Incorrect usage of the product can lead to common side effects, including various types of gastrointestinal distress such as nausea, diarrhea, vomiting, abdominal pain, constipation, and dark or discolored stool. The use of substandard products may significantly alter the dose, which can lead to suboptimal therapeutic effects. |
| 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. |
Recall Alert: Drug Product; Zolan 200mg/5ml Suspension (Batch # L-083) by Swat Pharmaceuticals, Swat
Recall Alert
| DRAP Alert No | No II/S/10-23-35 |
| Action Date | 4th 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 “Zolan suspension” as of substandard quality. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Zolan 200mg/5mL Suspension Reg.No 027683 | Metronidazole benzoate | Batch No L-083 Mfg. Date: May 2023 Exp. Date: Apr 2025 | Ms. Swat Pharmaceuticals, Saidu Sharif Swat. |
| Risk Statement: | Metronidazole benzoate oral suspension is commonly used to treat bacterial infections and intestinal parasites. Inaccurate use of the product may lead to common side effects like nausea, vomiting, diarrhea, and abdominal discomfort; more severe reactions, such as convulsive seizures and peripheral neuropathy, may also occur. The impact of the use of substandard products on the basis of noncomplying pH may significantly alter the stability, and solubility of the product and may interfere with its absorption which could lead to sub-optimal therapeutic effect. |
| 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. |
DRAP Participating in International Med Safety Week 2023 Social Media Campaign
From 6 to 12 November, Drug Regulatory Authority of Pakistan (DRAP) will take part in the global #MedSafetyWeek campaign, a collaboration involving more than 80 medicines regulatory agencies and several non-governmental organizations, to raise awareness about the importance of reporting side effects of medicines. With the theme ‘Who can report?’, this year’s campaign will focus on the key role of every patient, doctor, nurse, and pharmacist who reports a side effect and contributes to using medicines safely.
DRAP seek your support to enhance reporting of adverse drug reactions (ADRs) to ensure medicines on the market are acceptably safe.
Reports about side effects can be submitted easily through Med Safety App, DRAP med Vigilance e-reporting system or yellow reporting form.
For detail on how to report visit the link.
#MedSafetyWeek2023
Play your part in medicines safety. Whether you’re a patient, doctor, nurse, or pharmacist, you can help make medicines safer by reporting side effects to National Pharmacovigilance Centre, DRAP.
Through the #MedSafetyWeek campaign more than 80 countries will work together to improve the safety of medicines globally
All medicines agencies operate systems to detect and analyse side effects of medicines. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Constantly collecting and monitoring information from the reports received helps identify risks associated with medicines and take action to minimise harm.
#MedSafetyWeek is an international campaign of Uppsala Monitoring Centre (UMC).
DRAP emphasizes the importance of reporting side effects through Med Safety App, DRAP med Vigilance e-reporting system or yellow reporting form. All reports made to National Pharmacovigilance Centre (NPC) DRAP will be thoroughly assessed and examined to determine the right steps to be taken to protect the population from harm. Since 2018, NPC DRAP has received and processed over 30,000 reports in which patients, carers, and healthcare professionals have played a key role
“Every report is important in building more knowledge and understanding of the benefits and risks of medicines in clinical use and allows action to be taken to minimise risks.
“Reporting suspected side effects to the NPC DRAP helps to make medicines safer for patients all around the world. In some cases, it can result in better prescribing advice, which can improve patient outcomes.
“If you, or a patient you are supporting, experience a side effect with a medicine, make sure to report it to us promptly.”
Dr.Obaidullah,
National Pharmacovigilance Centre, DRAP, Pakistan
