URGENT: VOLUNTARY PRODUCT RECALL / MARKET WITHDRAWAL ***LIMITED ONLY TO SPECIFIC LOTS OF DAYTRANA***

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1 July 18, 2014 Dear Valued Customer: You should have already received a notification from Stericycle Inc. about a Voluntary Limited Recall/Market Withdrawal of Specific Lots of DAYTRANA (methylphenidate transdermal system). Attached for your reference is a copy of the official Stericycle notification, which includes a list of the affected lots. Please note the important points below. This voluntary action is limited to 21 specific lots of Daytrana listed on the Stericycle notification (attached) Adequate supplies of All Daytrana strengths remain in the distribution channels We encourage immediate replenishment of affected stock to meet ongoing patient needs. Only the specific lots provided in the Stericycle notification (attached) are being removed from the market. The reason for this voluntary action is the amount of effort necessary to remove the adhesive liner from the patch. As a result, caregivers and/or patients could have difficulty opening and using the patch. This voluntary product recall/market withdrawal is being conducted with the knowledge of the Food and Drug Administration. Please call Stericycle at or contact me directly if you have any questions with regard to the return of impacted product. Thank you for your continued support of Daytrana. Mike Michael Reheis Senior Manager Markets/ Trade Operations Noven Therapeutics, LLC O: (212) Empire State Building 350 Fifth Avenue, 37th Floor New York, NY Phone:

2 Product SPECIFICALLY AFFECTED LOTS OF DAYTRANA Voluntary Recall Lot Number Strength Count NDC# Expiry Date /2014 Reason Voluntary Market Withdrawal Lot Number Strength Count NDC# Expiry Date / / / / / / / / / / / / / / / / / / / /2015 Manufactured by: NOVEN PHARMACEUTICALS, INC. NOVEN THERAPEUTICS LLC is conducting a voluntary product recall/market withdrawal of the twentyone (21) above-listed lot numbers of the ADHD patches DAYTRANA. DAYTRANA patches in these lots no longer meet the release liner removal specification and/or z-statistic or may not meet the release liner removal specification and/or z-statistic at a date prior to product expiry. As a result, patients and caregivers could have difficulties removing the liners. The scope of this voluntary recall/market withdrawal is related ONLY to release liner peel properties for these identified lots. 5828_01_01AD_V1.1

3 Action Other Information 1. Stop dispensing or distributing and quarantine each of the above indicated DAYTRANA lots. 2. Please carry out a physical count of your affected inventory of the indicated DAYTRANA lots and record this data on the Business Reply Card that is included with this letter. Return the Business Reply Card to Stericycle, Inc. The Business Reply Card is Postage Paid. 3. If you DO NOT have the impacted product lots, you must still complete the enclosed Business Reply Card and return it to Stericycle, Inc. 4. If you DO have the impacted product lots to return, upon receipt of your completed Business Reply Card by Stericycle Inc., a Product Return Package, including: a DEA Form 222, Packing Slip and a prepaid UPS Return Service Shipping label will be forwarded to you by Stericycle on behalf of NOVEN THERAPEUTICS, LLC. A completed DEA Form 222 is required to process your return. 5. Once you receive the Product Return Package, complete the accompanying Packing Slip. Enclose the completed Packing Slip along with the returned product. Please attach the prepaid UPS Return Service shipping label to the outside of the return carton and return to: Stericycle, Inc. ATTN: Event Executive Drive, Suite A Indianapolis, IN This voluntary product recall / market withdrawal is being carried out to the retail level and is ONLY for the DAYTRANA lots indicated in this correspondence. 2. Notifications of this voluntary product recall / market withdrawal are being sent to all wholesale and retail accounts that may have received the indicated DAYTRANA lots. 3. It is not necessary to notify any patients who might have received the DAYTRANA lots indicated in this correspondence. 4. In the event a patient seeks information or attempts to return product, do not accept the product for return and direct them to contact NOVEN at Please do not return the impacted product to NOVEN PHARMACEUTICALS, INC. 6. For shipping assistance or questions about the recall / market withdrawal process, please contact Stericycle, Inc. at the address above or telephone number A credit will be issued to the pharmacy through your wholesaler or corporate headquarters for the total number of DAYTRANA boxes returned. In order for credit to be issued for returned product, it is critical that the pharmacy location obtain the Debit Memo number from the corporate headquarters or applicable finance team and include this number on the BRC. 8. This voluntary product recall / market withdrawal is being conducted with the knowledge of the Food and Drug Administration. 9. For medical questions please contact NOVEN DAYTRANA INFORMATION LINE at We appreciate your immediate attention and cooperation and sincerely regret any inconvenience caused by this action. 5828_01_01BD_V1.1

4 Frequently Asked Questions for Retail Pharmacies Daytrana Voluntary Product Recall / Market Withdrawal July What if my store does not have impacted product? Please complete the Business Reply Card (BRC) and mail it to the addressee (Stericycle). This will inform Stericycle that your store does not have impacted product. 2. What happens after I quarantine impacted product? A Business Reply Card (BRC) is included with this letter. You must complete the BRC, making sure to include lot numbers and counts of impacted product. This will allow Stericycle to generate a return package, which will include a DEA Form 222 for return of the product. 3. When should I expect to get the return package? You should expect to see the return package from Stericycle within 30 days of Stericycle s receipt of the completed BRC. 4. What happens if I lose the DEA Form 222? Contact Stericycle at A new form will be sent to you. 5. How do I return single patches from an opened tray? Please record the number of single patches for return in the appropriate space provided on the BRC. 6. What if a customer returns unused patches and wants an exchange? Please inform patients that you are not accepting the impacted product. Patients with affected product should be directed to call NOVEN DAYTRANA INFORMATION LINE at If additional impacted product is found in my store, can I get a new DEA Form 222? Yes. Contact Stericycle at to have a new form sent. 8. What happens if I want to return product not impacted by this voluntary product recall / market withdrawal? All product that is returned to Stericycle will be destroyed, even if it is not impacted by this voluntary product recall / market withdrawal. Product that is not impacted by this voluntary product recall / market withdrawal will not be reimbursed. Please contact your wholesaler or management (if applicable) for return policies. 9. How do I get reimbursed for returned product impacted by this voluntary product recall / market withdrawal? Reimbursement will be made in the form of a credit memo through the wholesaler. Contact Noven Therapeutics Customer Service at , for questions regarding reimbursement. 5828_01_02AD_V1.1

5 10. What if I haven t received my credit? Contact Noven Therapeutics Customer Service at and provide them with your reference/debit memo number or the Return ID from the return package. Please note that it is critical that the pharmacy obtain and include the Debit Memo number on the BRC for a credit to be issued. The pharmacy may need to contact corporate headquarters or the appropriate finance team to obtain this information. 11. What if my pharmacy chain has its own formal product recall / market withdrawal process? Please note on the BRC that you will be using your pharmacy chain s product recall / market withdrawal process to report and route the impacted product to Stericycle. 12. What if my pharmacy is unable to order Daytrana due to a temporary wholesaler stock out? Because this impacts a limited number of Daytrana patches, there should be sufficient supply of Daytrana to meet existing and new patient needs. However, if your pharmacy is unable to order Daytrana due to a temporary wholesaler stock out, please contact NOVEN DAYTRANA INFORMATION LINE at _01_02BD_V1.1

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7 No. Strength Lot Expiry Manuf. Date Avail. Quantity NDC # Status (mg) Number Date Date For Dist. (Patches) /2014 OOS 08/20/ /20/ , /2014 OOT 03/25/ /29/ , /2014 OOT 06/24/ /27/ , /2014 OOT 06/27/ /28/ , /2015 OOT 09/10/ /19/ , /2015 OOT 10/15/ /17/ , /2015 OOT 10/23/ /19/ , /2015 OOT 10/24/ /06/ , /2014 OOT 04/30/ /28/ , /2014 OOT 08/22/ /30/ , /2014 OOT 05/17/ /23/ , /2014 OOT 08/07/ /09/ , /2015 OOT 11/06/ /08/ , /2015 OOT 01/09/ /15/ , /2015 OOT 11/12/ /21/ , /2015 OOT 11/11/ /08/ , /2015 OOT 11/08/ /17/ , /2015 OOT 09/09/ /18/ , /2015 OOT 09/05/ /15/ , /2015 OOT 11/21/ /21/ , /2015 OOT 11/26/ /25/ ,060