Recall All Batches of pharmaceutical products manufactured by Les Laboratoires Medis

2024-01-03

Product Description :

الاسم التجاري	الاسم العلمي	رقم التسجيل	رقم التشغيلة المتأثرة	الشركة الصانعة
Trade Name	Scientific Name	Register Number	Affected batch number	Manufacturer
MEDICAINE 2% CARTRIDGE	MEPIVACAINE HYDROCHLORIDE,ADRENALINE	2-560-12	جميع التشغيلات حتى تاريخه	LES LABORATOIRES MEDIS
MEDICAINE 3% CARTRIDGE	MEPIVACAINE HYDROCHLORIDE	3-560-12
OMECURE 40 MG POWDER FOR I.V. INJECTION	OMEPRAZOLE	3008222563
FLUKAS 200 VIAL	FLUCONAZOLE	5-560-12
FLUKAS 100 VIAL	FLUCONAZOLE	4-560-12
ZOTIMOS 4MG VIAL	ZOLEDRONIC ACID	12-560-19
TOSTAF 500 mg Vial	VANCOMYCIN	1709234220
TEICO 200 mg Vial	TEICOPLANIN	1411234468
TEICO 400 mg Vial	TEICOPLANIN	1411234470
MEPROSON 40MG POWDER FOR INJECTION	METHYLPREDNISOLONE	10-560-19
MEPROSON 500 MG POWDER FOR INJECTION	METHYLPREDNISOLONE SODIUM SUCCINATE	11-560-19
LEVODIS 5 mg/ml Solution For Injection	LEVOFLOXACIN	2803233438
REMIFENTANIL MEDIS 1 MG VIAL	REMIFENTANIL HYDROCHLORIDE	13-560-19
REMIFENTANIL MEDIS 5 MG VIAL	REMIFENTANIL HYDROCHLORIDE	14-560-19
ONDANSETRON MEDIS 8MG F.C.TABLET	ONDANSETRON	15-560-19
FENTANYL MEDIS 10 ml Ampoule	FENTANYL	1512211479
FENTANYL MEDIS 2 ml Ampoule	FENTANYL	1512211480
ENOXA	ENOXAPARIN SODIUM	2906222278
ENOXA	ENOXAPARIN SODIUM	2906222279
ENOXA	ENOXAPARIN SODIUM	2906222280
ENOXA	ENOXAPARIN SODIUM	2906222281
Paracetamol Medis	PARACETAMOL	1206233787

Issue :

SFDA has issued a recall of all products above due to GMP non-compliance based on inspection observations during the visit that carried out at Les laboratoires medis which may affect the quality and safety of finished pharmaceutical product.

Recommendations :

For healthcare professionals,Stop dispensing the above products immediately. Embargo/Quarantine all remaining stock. Affected batch should be returned to the supplier.

for patients

Consult your healthcare provider prior to discontinuing use of the affected products, or for any health concerns.
Contact the recalling firm or SFDA if you have any questions about the recall.
Adverse reactions or quality problems experienced with the use of this product may be reported to Saudi Vigilance either online or call center (Call 19999).

Recall All Batches of pharmaceutical products manufactured by Les Laboratoires Medis