07. Recall Alert (Human) – DTLs Punjab declared substandard drug products.

Salateen Philip Recall Alerts March 11, 2026March 11, 2026Recall

Recall Alert


	DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.

DRAP Alert No	N^oI/S/03-26-07
Action Date	11 March, 2026.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard & Adulterated’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection SORIDE Each mL contains: Sodium Chloride USP….9mg (Reg # 044017)	SR260004	M/s Bosch Pharmaceuticals (Pvt) Ltd. 221 Bosch House Sector 23 Korangi industrial Area Karachi. (DML # 000350)	The sample is declared as “Misbranded” under Section 3(s)(iv) of the Drugs Act, 1976 due to non-compliance with USP labelling requirements (osmolar concentration not stated on the label as required). The sample is also declared “Sub-Standard” on the basis of visible particulates in injection.
2.	Injection Neudex Each ml contains: Dexamethasone sodium phosphate eq. to dexamethasone phosphate……4mg (Reg # 042943)	DX030	M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)	The above sample is Adulterated as per The Drugs Act 1976, 3 (a)(iv) on the basis of Identification and Quantification of Dexamethasone (base).

Risk Statement:	The cited products, Injection SORIDE (Sodium Chloride 0.9%) and Injection Neudex (Dexamethasone Sodium Phosphate 4 mg/mL), present significant clinical and regulatory risk. SORIDE has been declared misbranded due to non-compliance with USP labeling requirements (absence of osmolar concentration), which may lead to improper clinical use in sensitive populations such as neonates, critically ill, or electrolyte-imbalanced patients. More critically, the presence of visible particulates in a parenteral preparation classifies it as sub-standard, posing a direct risk of embolism, phlebitis, pyrogenic reactions, and systemic inflammatory responses. Injection Neudex has been declared adulterated based on failure in identification and quantification of dexamethasone (base), indicating potential presence of incorrect strength, substitution, or degradation. This may result in therapeutic failure in emergency conditions such as anaphylaxis, cerebral edema, severe asthma, or shock, where corticosteroids are life-saving. The population most likely to be affected includes hospitalized patients, emergency cases, pediatric and ICU patients receiving IV fluids or corticosteroid injections. The overall risk level is assessed as high, particularly because both products are injectable formulations administered systemically, and any quality defect may result in immediate and serious patient harm.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks 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 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 these 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.