A quality problem is a fault with the product itself rather than a reaction to it: tablets that look wrong, packaging that does not match, a broken seal, an unexpected smell, or a product you suspect is counterfeit.
These are reported to SAHPRA using the same form that covers adverse drug reactions, so you do not have to work out which category your situation falls into. If something happened to you as well as to the product, report both together.
Quick answer: when and how to report a suspected side effect
What information to record
Keep the product and the packaging. Do not return it, discard it or finish the pack. For a quality problem the item itself is the evidence, and the batch number on the carton is what allows the problem to be traced to a specific manufacturing run.
Photograph the packaging, the batch number and whatever looks wrong before doing anything else.
Where reporting fits into medicine safety
Quality reports are how batch problems get identified, and they are the usual starting point for a recall. See medicine recalls in South Africa.
Who can report a side effect or adverse drug reaction?
What information to record
Anyone. Your pharmacy is often the fastest first step, since they can check whether other packs from the same batch are affected, take the product back, and supply a replacement.
Where reporting fits into medicine safety
Report even if you were not harmed. A defect noticed before anyone took the medicine is exactly the report that prevents harm to someone else.
What information should you collect before reporting?
What information to record
- Product name, strength and dose form
- Batch or lot number and expiry date
- Where and when you obtained it, including whether it was bought online or abroad
- Exactly what is wrong: appearance, smell, packaging, count, or labelling
- Whether anyone took it, and any symptoms that followed
- How it was stored, since heat and damp can alter a product
Where reporting fits into medicine safety
Things that count as a quality problem: tablets that are broken, discoloured, unusually shaped or a different size from previous packs; an unexpected or strong smell; missing or damaged contents; a broken tamper seal; a leaking or cracked container; labelling that does not match the contents; a product with no batch number or expiry date; or anything you suspect is falsified. See falsified medicines and substandard medicines.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- The adverse drug reaction and quality problem form, which covers both
- SAHPRA reporting links published on the health products vigilance page
- Through your pharmacist, who can escalate to the supplier as well
- Through the company that markets the product
Where reporting fits into medicine safety
SAHPRA publishes resulting actions through its product recalls and rapid alert pages.
What counts as a serious or unexpected side effect?
Red-flag symptoms
If someone took the product and is unwell, treat that first. Get emergency help for difficulty breathing, facial or throat swelling, chest pain, seizures, or a blistering rash. See serious medication side effects.
When to contact a doctor, pharmacist, or emergency service
Do not simply stop a medicine for a serious condition because the pack looks wrong. Contact your pharmacy for a replacement, since going without can be more harmful than the defect.
What happens after a report is submitted?
What information to record
Note the batch number before handing the product over, so you keep a record of what you had.
Where reporting fits into medicine safety
Quality reports may lead to investigation of the batch, a recall, or a rapid alert if the issue is urgent. See how to check for a recall.
Medical Disclaimer: This content is for informational and educational purposes only and does not constitute medical diagnosis, prescription, or professional advice. Always read the patient information leaflet and consult a qualified doctor or pharmacist regarding any medicine or health concern.