Recall All Batches of 11 sterile pharmaceutical products manufactured by Saudi Pharmaceutical Industries

Recall All Batches of 11 sterile pharmaceutical products manufactured by Saudi Pharmaceutical Industries

2023-04-20

Product Description :

 

الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

Adijet 1 mg/ml Injection

Adrenaline 1mg/ml

1304210679

جميع التشغيلات حتى تاريخه

Saudi Pharmaceutical Industries, SPI

EPINOR 1 mg/ml Injection

Norepinephrine Bitartrate 1mg/ml

14-430-18

Ondex 2 mg/ml Injection

Ondansetron 2mg/ml (4 ml)

1201210409

Ondex 2 mg/ml Injection

Ondansetron 2mg/ml (2 ml)

1201210410

RELIPAN 25 mg/ml Injection

Diclofenac Sodium 25mg/ml

0201221544

SODIUM CHLORIDE 0.9% Injection

Sodium Chloride 0.9% (10 ml)

27-430-19

SODIUM CHLORIDE 0.9% Injection

Sodium Chloride 0.9% (5 ml)

28-430-19

SODIUM CHLORIDE 3% I.V. Injection

Sodium Chloride 3% (10ml)

25-430-19

SODIUM CHLORIDE 3% I.V. Injection

Sodium Chloride 3% (5 ml)

26-430-19

STERILE WATER for Injection

Water (10ml)

16-430-18

STERILE WATER for Injection

Water (5ml)

17-430-18

Issue :

Saudi FDA has issued a recall of all products above due to GMP non-compliance based on inspection observations during the visit that carried out at Saudi Pharmaceutical Industries, Saudi Arabia, 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.
  • Contact the recalling firm or Saudi FDA 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 11 sterile pharmaceutical products manufactured by Saudi Pharmaceutical Industries