MAKAN SAFETY

Monday, May 24, 2010 @ 4:36 AM

PRODUCT RECALL

Definition of product recall:
A permanent removal of the affected products from the market OR temporary removal of product for correction which after that may be returned to the market for sale

Who is involved in product recall in Singapore?
Health Science Authority (HSA).

How do we classify the recall?
There are different levels and classification of recall involved depending on the hazard and the extent of product distribution. These will be determined after the discussion between HSA and the company.

CLASSIFICATION
(1) Class 1 Recall
Product that poses a life threatening situation to consumers. Example: Products with major labeling problem

(2) Class 2 Recall
Product that in unlikely to cause serious harm to consumers.Example: Products with minor labeling problem or fail to meet product specification.

LEVELS
There a total of 3 levels of recall and each recall depends on the extend of distribution area and the classification of defect.
(1) Wholesale level
Involves wholesale sales which may include the wholesalers and retail pharmacies.

(2) Retail level
Involves retail pharmacies as well as private hospitals pharmacies and all medical related establishments. It also includes other retail outlets such as supermarkets as well as the wholesale level.

(3) Consumer level
Involves patients, consumers and the above 2 levels (Wholesale & retail)

How do we then implement product recall? (In Singapore)
Step 1: Company receives a complain.
Step 2: Company to alert the authorities by submitting a form within 24hrs.
Step 3: Discussion with the HAS on the classification and level of the recall.
Step 4: A recall has to be done thus the company have to do the following.
I. Cease all sales of defective products immediately.
II. Keep all defective stocks
III. Inform all affected wholesalers / distributors / retailers to do likewise first through verbal communication and followed by recall letter
Step 5: Arrangement with the affected wholesalers/ distributors/ retailers on collecting the defective products and keeping in the warehouse.
Step 6: Complete the recall and submit full recall report to HSA's Enforcement Branch recall officer within 3 weeks from the date of initiation of recall as well as submit
I. Proof of action taken on recalled stocks (Re-export documents or Certificate of destruction) within 3 months from the date of completion of recall
II. Submit proposal of corrective action(s) for approval (if any)
III. Institute corrective action(s) on approval (if any)

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