Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUGS TESTING LABORATORY.
| DRAP Alert No | No II/S/12-25-126 |
| Action Date | 30 December, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratory (DTL) Punjab informed that the samples of below mentioned drug products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Injection Cara-Doba 5ml Each 5ml Ampoule contains: Dobutamine HCl eq. to Dobutamine …. 250mg (Reg. # 054987) | 24J009 & 25E004 | M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629) | Batch # 24J009 The sample has been declared Sub-Standard, on the basis of Physical Description and Visible Particulates. Batch # 25E004 The Color has been changed to dark brown with crystallization. (Physical Description and Visible Particulates). |
| Risk Statement: | The administration of sub-standard injectable Dobutamine with visible particulates, discoloration, and crystallization poses a serious and immediate risk to patient safety, particularly for critically ill patients, cardiac patients, and those receiving intensive or emergency care, where Dobutamine is commonly used for acute cardiac support. Such quality defects may lead to embolism, phlebitis, systemic infections, reduced therapeutic efficacy, or unpredictable pharmacological response, potentially resulting in treatment failure, hemodynamic instability, or life-threatening complications, thereby warranting urgent regulatory intervention. |
| 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. |