Compound Sodium Lactate Infusion BP (Ringer Lactate Solution for Injection)

Summary

Date Recall was issued:
Product Name:

 

Product Type:
Manufacturer:
Recalling Firm:
Batch(es):
Manufacturing Date:
Expiry Date:
Reason for Recall:
2nd May 2025
Compound Sodium Lactate Infusion BP (Ringer Lactate Solution for Injection)
Drug
Atlantic Life Science Ltd
Atlantic Life Science Ltd
02E92w, 02E93w, 02E94w
02/2025
01/2028
This recall is necessitated as a result of laboratory analysis conducted on samples of the products by the FDA Centre for Laboratory Services and Research, which indicated that the samples did not meet the requirements of NMT 0.25iu/ml for bacterial endotoxin as per the BP specifications. This makes the products substandard and therefore not recommended for the intended use

Announcement

This recall is necessitated as a result of warehouse market surveillance conducted at the warehouse. Actual product specification is a powder for oral suspension. The affected batches were caked and not free flowing. This makes the product substandard and therefore not recommended for its intended use.

SHOPRITE PRODUCT RECALL DETAILS

Picture18