Rapid Alert: Urgent Recall of Suspected Products for Contamination of DEG / EG

Rapid Alert

Urgent Recall of Suspected Product for contamination of DEG / EG

DRAP Alert NoNoI/S/02-23-8
Action Date20th February 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions
4. General Public
Problem StatementMedical Control Agency, Gambia has issued a Safety Alert Ref: – MCA/AD/23/MJK(029) dated 13th February,2023 for KOF Relief Syrup bearing Batch# L394, manufactured by M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan due to presence of Ethylene Glycol (EG) at unacceptable levels. DRAP Inspectorate has initiated the investigation based on this information, and decided to recall all the suspected products manufactured by the firm using the same source of excipient i.e Glycerin and Propylene Glycol (PG).

The details of suspected contaminated products are as under: –

Therapeutic Goods Affected:-

SrProduct NameCompositionBatch #Manufactured by (as stated on label)
1Bromgen Syp 100mL

(Reg. Export Only)
Bromhexine HClL392M/s Davis Pharmaceutical Laboratories,
Islamabad-Pakistan
2Kof Relief Syp 100mL
 
(Reg, Export Only)
Chlorpheniramine Maleate
Ammonium Chloride
Sodium Citrate
Menthol
Green Banana Flavour
L394-do-
3Macofen Syp 100mL
 
(Reg, Export Only)
IbuprofenL395-do-
4Vomitil Suspension 120mL

(Reg, Export Only)
DomperidoneL400, L408,
L414,
-do-
5Asperfin Syp 60mLKetotifenL401-do
6Davis Tonic Syrup
(250mL, 120ml)
Vitamin B12
Vitamin B1 HCl
Vitamin B2
Vitamin B6
Vitamin B3
Folic Acid
Vitamin B5
Sodium Glycerophosphate
Manganese Sulphate
Ferric Ammonium Citrate
CS07, CS20,
CS21, CS23,
CS30, CS31,
CS42, CS70,
CS71, CS159
-do-
7Zinc Syp 60mLZinc Sulphate MonohydrateCS06, CS36,
CS37, CS38,
CS39, CS45,
CS46, CS47,
CS48, CS60,
CS75, CS76,
CS80, CS81,
CS83, CS92,
CS93
-do-
Action InitiatedThe manufacturing company has been directed to immediately recall the suspected batches of these products from the market. All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying these batches of products. The remaining stock should be quarantine and return to the supplier / company. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products.

-Adverse reactions or quality problems experienced with the use of these product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 these products and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

-All therapeutic goods must be obtained from the 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.

Lists of Applications for Provisional Enlistment of Alternative Medicines and Health Products

Following is the provisional list of applications are received for provisional enlistment of products with the Division of Health & OTC, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. Applicant firm are requested to furnish comments with respect to submitted applications within 30 days of the uploading of this list, if any. The comments received within 30 days of the publication of this list will be given due consideration, after which a final list will be uploaded on the website. Comments received after due date shall not be entertained. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of date mentioned against each application

These lists are prepared according to types of products and categories of applicant’ firms, as under:-

110th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

The 110th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 3rd August, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

109th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

The 109th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 5th July, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

Submission of Deficient Information / Documents (Enlistment Evaluation Committee (EEC) 92nd meeting held on 30th July, 2021)

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 92nd meeting held on 30th July, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.

Submission of Deficient Information / Documents (Enlistment Evaluation Committee (EEC) 91st meeting held on 13th July, 2021)

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 91st meeting held on 13th July, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.

Date Wise FIFO List of Applications For Provisional Enlistment Of Products Applied By Nutraceutical Firms And Firms Having Herbal/Unani Sections Along With Nutraceutical Sections (FIFO List 2020)

“In continuation to the previous FIFO list uploaded on official website of Drug Regulatory Authority of Pakistan on 29th June, 2021 and after incorporating the responses submitted by the firms within the stipulated time, following is the list of applications received for provisional enlistment of products with the Division of Health & OTC Products, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of R&I date mentioned against each application.

Please note that formulations of all products of respective companies must be forwarded in MS Word & MS Excel Formats (Soft Copy) annexed at the end of this document (Annexure-I) to the official e-mail hotcdivisiongmail.com of Health & OTC Division with the title “M/s…………. FIFO List 2020” within 15 days positively. Soft Formulations should be provided as per data given in Form-3 already submitted with dossier in hard form. Any discrepancy found in the submitted data in soft and hard shall be liable to rejection of the product application.

Date Wise FIFO List Of Applications For Provisional Enlistment Of Products Applied By Homeopathic Firms (FIFO List 2020)

“In continuation to the previous FIFO list uploaded on official website of Drug Regulatory Authority of Pakistan on 29th June, 2021 and after incorporating the responses submitted by the firms within the stipulated time, following is the list of applications received for provisional enlistment of products with the Division of Health & OTC Products, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of R&I date mentioned against each application.

Please note that formulations of all products of respective companies must be forwarded in MS Word & MS Excel Formats (Soft Copy) annexed at the end of this document (Annexure-I) to the official e-mail hotcdivisiongmail.com of Health & OTC Division with the title “M/s…………. FIFO List 2020” within 15 days positively. Soft Formulations should be provided as per data given in Form-3 already submitted with dossier in hard form. Any discrepancy found in the submitted data in soft and hard shall be liable to rejection of the product application.

Submission of deficient information / documents (Enlistment Evaluation Committee (EEC) 90th meeting held on 17th June, 2021)

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 90th meeting held on 17th June, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.