Falsified / Spurious Cilapen 500mg Injection
|DRAP Alert No||NoI/S/02-23-13|
|Action Date||21st February 2023|
|Target Audience||1. 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 Statement||Federal Inspector of Drugs Karachi took the sample of Cilapen 500mg Injection and sent to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (ii) of the Drugs Act 1976.|
The product detail as mentioned on the label is as under: –
Therapeutic Goods Affected:-
|Sr||Product Name||Composition as per label||Batch #||Manufactured by (as stated on label)|
|1||Cilapen 500mg Injection|
Mfg. Date: 06-2022
Exp. date: 03-2024
|Imipenem + Cilastatin||CP19014||Ms. Bosch Pharmaceuticals (Pvt.) Ltd., Karachi.|
Following is the comparison of sample against the original pack of the product: –
|S.N||Description||Original pack of the manufacturer (Bosch)||Sample pack (Spurious/Falsified)|
|1||Batch number for vial||CP19014||CP19014|
|5||Batch number of WFI on the ampoule and carton||Both same as WI19085||WI21042 on the ampoule where as WI19085 on the carton|
|6||Color of WFI ampoule||Blue||Orange|
|7||Printing of descriptions of product||Over-printing batch no. manufacturing date and expiry date||Plain printing (pre-printing)|
|8||Font size and style||As per standard approved Bosch Artwork.||Different from the company.|
|9||Direction insert/leaflet||As per standard approved Bosch Artwork.||Paper size and quality, color, printing is totally different from that of the company.|
|Risk Statement:||Imipenem and Cilastatin injection is used to treat certain serious infections that are caused by bacteria, including endocarditis and infection of respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint. Wrongful use / misleading information as mentioned above may leads to adverse reactions including but not limited to following:|
· Severe stomach pain, diarrhea that is watery or bloody.
· Upper stomach pain, loss of appetite.
· Jaundice and fever.
· Seizure; light-headed feeling, like you might pass out.
Consequences of use of Falsified/Spurious Drugs are:
· Falsified/Spurious drugs may contain toxic doses of dangerous ingredients and cause mass poisoning.
· Contributes to the progression of antimicrobial resistance and drug-resistant infections.
· Poor-quality medicines compromise the treatment of chronic and infectious diseases, causing disease progression, drug resistance, and death.
|Action Initiated||The Regulatory Field Force has been directed to increase the surveillance activities in the market to confiscate this batch of product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this batch product. The remaining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of this products.|
|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.