27 Apr CP Sports Infusion” (Glutathione: 2g/50ml)
Other ingredients: [Thiamine: 260mg/50ml; Riboflavin: 2mg/50ml; Nicotinamide: 100mg/50ml; Pyridoxine: 5mg/50ml; D- Panthenonate: 5mg/50ml;
Magnesium: 1g/ 50ml and Methylcobalamin: 250ug/50ml]
| Company name & Address | registration number | Batch number | Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
|
Compounding Pharmacy of South Africa (CPSA). 2 Eaton Avenue, |
N/A (product by compounding pharmacy) |
IV44762;
IV44821;
IV44830;
IV44856 |
IV44762: IV44821: IV44830: IV44856 |
50ml injectable vial |
IV44762: 05-10-2022; IV44821: 10-10-2022; IV44830: 11-10-2022; IV44856: 12-10-2022 |
Class I Type C
|
21 Oct |
Reason for recall
The recall is due to reports of patients that have reacted to IV medicines, compounded by CPSA, and issued on prescription to medical practices. The medical practitioners of these patients communicated the information to the Compounding Pharmacy (the recall was initiated after the company (CPSA) was notified of patients being hospitalized). Details of complaints: 1 complaint: Nausea, vomiting, body aches, tachycardia, muscle weakness, headaches & shivers.
35 Complaints: Nausea, vomiting, body aches, tachycardia, muscle weakness, headaches & shivers.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from dispensing the affected batches. An urgent notification (letter) was sent to all practices that received IVs containing the affected batches, as well as additional batches as a precautionary measure with immediate effect.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all clients and recall initiated.
distributed to all distribution points and recall initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.