Adco-Napacod tablets (Paracetamol 500 mg and Codeine Phosphate 10mg)

Adco-Napacod tablets (Paracetamol 500 mg and Codeine Phosphate 10mg)

Company name & Address:  

registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First distributed

 

Re-call Classification

 

Re-call Date

Adcock Ingram Limited.

1 New Road, Midrand, 1685

 

B/2.8/1401

   AD0433

AC1264

 

02-2026

 

06-2025

 

1000’s

 

25 June-2021

 

08 Oct-2020

 

Class II Type B

23 June 2022

 

Reason for recall

The products are being recalled due to quality defect: the company received customer complaints reporting discoloration of tablets and/or discoloured silica gel (complaints were either about discoloured silica gel sachets only or discoloured silica gel sachets and tablets with which the sachets had direct contact).

 

Advice to HCPs/Distributors/Public:

Affected stock has been blocked for distribution and the product placed on hold at Adcock Ingram distribution centers.

Proposed action taken and its urgency: SAHPRA approved recall letter distributed to all distribution points, 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.

Download latest version
Version: 1
Date Updated: 23/06/2022
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance