Recall Alert: Drug Product; Dolor DS 100mg/5mL Suspension (Batch # 1236,1237 and 1238) by Adamjee Pharmaceutical, Karachi

Recall Alert

DRAP Alert NoNo II/S/10-23-42
Action Date30th 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 the03 Batches of product “Dolor DS Suspension” as of substandard quality.
The detail of the affected product is as under:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Dolor DS Suspension  
Reg.No 14451
Mefenamic AcidBatch No1236, 1237, 1238
Mfg. Date: March 2023
Exp. Date: March 2025
M/s. Adamjee Pharmaceuticals
(Pvt.) Ltd, Karachi
Risk Statement:Mefenamic acid is used for the short-term relief of mild to moderate pain from various conditions such as headache, dental pain, menstrual cramps, and muscle aches. Inaccurate use of the product may lead to common side effects like skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Impact of use of substandard product on basis of pH test may significantly altered the solubility and interfere with its absorption which may leads 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

-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 ProfessionalsDRAP 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.

Decisions of 62nd Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in its 62nd meeting has deferred the following applications of registration of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.