GARDASIL 9 Prefilled Syringes
Normal Priority / Pharmaceutical / ECRI: P4902 / 01 / Merck issued a Voluntary Recall on the following product(s). Reason: May Be Labeled with Incorrect Lot Number and Expiration Date. **Identify any affected product in inventory**
1. Examine your inventory and quarantine all GARDAS1L9 vaccine cartons and pre-filled syringes labeled as belonging to Lot N029069 (Expiration 17MAY2020) or Lot M743R56 (Expiration 01/02/03).
--Once quarantined, product should be returned according to the procedure described below.
--If you have further distributed material printed with either Lot N029069 (Expiration 17MAY2020) or Lot M743R56 (Expiration 01/02/03), conduct a sub-recall and notify your direct customers of this product recall (see step 6).
2. Complete the enclosed postage-paid business reply card and packing slip. Be sure to indicate the number of cartons and/or pre-filled syringes you have returned or will be returning.
3. Complete and return the enclosed business reply card as soon as possible.
4. Return a copy of the business reply card, even if you do not have any of the product subject to this recall, so that we can be sure to account for all product distributed.
5. Return the shipping label and all of the product subject to this recall that is in your inventory, using the prepaid shipping labels, to:
Attn: Event 8425
2670 Executive Drive, Suite A
Indianapolis, IN 46241
If you require additional prepaid shipping labels, packing slips or business reply cards, contact Stericycle, Inc.
6. If you have further distributed material printed with either Lot N029069 (Expiration 17MAY2020) or Lot M743R56 (Expiration 01/02/03)
--Notify customers to whom you distributed such product by sending them copies of the following:
------this "Dear Customer Letter" and
------the enclosed Notification of Vaccine Recall
--Instruct customers to contact Stericycle, Inc., at 877-643-8438, for product return instructions. Stericycle, Inc. will provide all customers with prepaid shipping labels, packing slips and business reply cards.
Complete and return the enclosed business reply card as soon as possible.
For questions about the recall process (including how to return the recalled product), contact:
--Stericycle, Inc.: 877-643-8438
Customers will be reimbursed for returned product at the price applicable to each customer at the time of purchase.
Customers will be reimbursed for product returned under this recall in the form of a credit or a check, subject to Merck's discretion.
For Further Information:
Merck National Service Center
Tel.: (800) 672-6372 Select Prompt #1 then Prompt #2 (Monday to Friday 8:00 AM to 7:00 PM EST)
Note: See Image on Message under Additional Documentation/Attachment for enclosed referenced document(s) and manufacturer letter.