Update: Ferring Pharmaceuticals issues voluntary product recall UPDATE of Desmopressin Acetate (Nasal Spray) 1.5 mg/mL Stimate.
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
August 12, 2020 Update: Ferring Pharmaceuticals issues voluntary product recall UPDATE of Desmopressin Acetate (Nasal Spray) 1.5 mg/mL Stimate®. Dear ASD Healthcare Customer: This updated letter is to provide you with additional information regarding the Stimate® Nasal Spray recall communication that was sent to you on July 21, 2020. Stimate® Nasal Spray is owned and manufactured by Ferring Pharmaceuticals, Inc., and distributed and sold by CSL Behring LLC. After further collaboration with FDA, Ferring is now extending this recall to the consumer/user level. Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of Stimate® Nasal Spray 1.5 mg/mL to the consumer level. This product is being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were identified during routine testing. The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (i.e., hyponatremia) which could potentially lead to seizure, coma, and death. To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed. Ferring is recalling all batches of Stimate® Nasal Spray. The table below provides detail for all impacted batches of Stimate® Nasal Spray that were shipped to CSL Behring beginning on December 15, 2017:
Ferring provided the affected lot information below:
Product Description NDC Lot Numbers Expiration Date
R15953C 30-Sep-22
R14667A 31-Aug-22
R14101A 31-Jul-22
R13648A 30-Jun-22
R13271A 30-Apr-22
R11845A 30-Apr-22
P13756P 31-Aug-21
Stimate® 0053-6871-00 P13755A 30-Jun-21
P13212H 30-Jun-21
P13209L 30-Apr-21
P11326C 28-Feb-21
P11326AA 28-Feb-21
N17445N 31-Dec-20
N15378G 30-Sep-20
N14134C 31-Jul-20
To comply with the withdrawal, we ask for your cooperation in taking the following
action:
• Please examine your stock immediately to determine if you have the affected lot on
hand. If you have product from this lot, cease use immediately and quarantine the
affected product.
• Use the Request a Return tool to get started. Return product to ASD
Healthcare's warehouse (address listed below)
Warehouse Supervisor
ASD Healthcare
345 International Blvd, #400A
Brooks, KY 40109
For the full recall notice, please view the attached document on the following pages.
If you have any questions or concerns, please contact ASD Healthcare's customer service
at 800.746.6273.Date: August 11, 2020
URGENT: VOLUNTARY PRODUCT RECALL UPDATE
Reclassification-Consumer/User Level
Subject: Desmopressin Acetate (Nasal Spray) 1.5 mg/mL
Stimate®
Batch Numbers: See chart below
NDC Number: 0053-6871-00
Dear Customer:
This updated letter is to provide you with additional information regarding the Stimate® Nasal Spray recall
communication that was sent to you on July 21, 2020. Stimate® Nasal Spray is owned and manufactured by Ferring
Pharmaceuticals, Inc., and distributed and sold by CSL Behring LLC. After further collaboration with FDA, Ferring is now
extending this recall to the consumer/user level.
Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of Stimate® Nasal Spray 1.5 mg/mL to the
consumer level. This product is being recalled due to superpotency or amounts of desmopressin higher than specified.
These out of specification results were identified during routine testing.
The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in
the blood (i.e., hyponatremia) which could potentially lead to seizure, coma, and death. To date, Ferring has not
received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal
spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the
timeframe that the affected product was distributed.
Ferring is recalling all batches of Stimate® Nasal Spray. The table below provides detail for all impacted batches of
Stimate® Nasal Spray that were shipped to CSL Behring beginning on December 15, 2017:
Product NDC Batch Expiry Date
R15953C 30-Sep-22
R14667A 31-Aug-22
R14101A 31-Jul-22
R13648A 30-Jun-22
R13271A 30-Apr-22
R11845A 30-Apr-22
P13756P 31-Aug-21
Stimate® 0053-6871-00 P13755A 30-Jun-21
P13212H 30-Jun-21
P13209L 30-Apr-21
P11326C 28-Feb-21
P11326AA 28-Feb-21
N17445N 31-Dec-20
N15378G 30-Sep-20
N14134C 31-Jul-20
CSL BehringThis recall is to be conducted to the consumer level and is being conducted with the knowledge and approval of the
Food and Drug Administration.
As previously communicated, examine your current inventory and if you have an impacted batch, contact your
Authorized Distributor’s Customer Service to facilitate a return to them.
We are requesting you take the following additional actions:
Send the enclosed Dear Patient Letter to any patient that received the impacted product.
Patient Returns will be handled directly through My SourceSM, CSL Behring’s Patient Resource Center (contact
information below).
If patients have questions regarding returns, please direct them to My SourceSM , CSL Behring’s Patient Resource
Center:
My SourceSM, CSL Behring’s Patient Resource Center Information: Phone: 1-800-676-4266
PLEASE NOTE THAT RETURNS ARE LIMITED TO INVENTORY OF STIMATE® NASAL SPRAY BATCHES LISTED IN THE TABLE
ABOVE ONLY. THERE WILL BE NO CREDIT GIVEN FOR RETURNS OF ANY OTHER BATCHES OF STIMATE® NASAL SPRAY
THAT YOU HAVE IN INVENTORY OR RETURNED BY YOUR CUSTOMERS.
If you have any questions concerning specifics of the recall, please contact CSL Behring Medical Information.
CSL Medical Information: Phone: 1-800-504-5434
Email: MedinfoNA@cslbehring.com
Thank you for your cooperation in this matter.
Sincerely,
Paul Stapel Brian Puglisi, PharmD
Director, Quality Assurance Quality Assurance Manager
Global Quality
Ferring Pharmaceuticals, Inc. CSL Behring, L.L.C
CSL BehringDDRA
URGENT: VOLUNTARY PRODUCT RECALL
Subject: Desmopressin Acetate (Nasal Spray) 1.5 mg/mL
Stimate®
NDC Number: 0053-6871-00
August 11, 2020
Dear Valued Patient,
CSL Behring is committed to ensuring that its products adhere to the highest quality standards. As such, we must
notify you of a recall of Stimate® Nasal Spray. Stimate® Nasal Spray is owned and manufactured by Ferring
Pharmaceuticals, Inc., and distributed and sold by CSL Behring LLC.
Ferring has issued a voluntary recall of Stimate® Nasal Spray as a precaution due to the risk of amounts of
desmopressin higher than specified, also known as superpotency. This risk was identified when routine testing
showed higher than expected concentrations of desmopressin in some vials of the product. This recall is being
conducted with the knowledge of the U.S. Food and Drug Administration.
Exposure to a higher than expected amount of desmopressin can cause water retention and hyponatremia
(decrease of sodium concentration in the blood). Mild symptoms can include nausea, headache and fatigue.
Severe symptoms can include confusion, seizures, coma, and death as described in the Stimate® Prescribing
Information. If you have medical questions about Stimate®, please contact CSL Medical Information by Phone at
1-800-504-5434 or by emailing MedinfoNA@cslbehring.com.
You are receiving this letter because you may have received product impacted by this recall.
Patients using Stimate® Nasal Spray or their caregivers should contact their healthcare providers immediately to
discuss available treatment options before returning the medication.
If you have any quantity of Stimate® Nasal Spray in your possession, please contact My SourceSM, CSL
Behring’s Patient Resource Center at 1-800-676-4266 for instructions on how to return it as a part of this
recall. To further demonstrate our commitment to the patients who use CSL Behring products, we have
established a program to allow you to receive remuneration upon return of the product. If you return
Stimate® Nasal Spray purchased in the U.S. on or after January 10, 2018, you may be eligible for some
remuneration. Please contact My SourceSM, CSL Behring’s Patient Resource Center at 1-800-676-4266.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's
MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or
call 1-800-332- 1088 to request a reporting form, then complete and return to the address on the pre-
addressed form, or submit by fax to 1-800-FDA-0178
Adverse events may also be reported to CSL Behring’s Adverse Event Reporting line by calling 1-866-915-
6958 or by emailing adverse.events.global@cslbehring.com
We thank you for your understanding and cooperation.
Debra Bensen-Kennedy, MD
VP Medical Affairs, CSL BehringYou can also read
