Recalls / Class I
Class ID-1506-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
- Affected lot / code info
- Lot # N14134C, exp. date 07 2020 N15378G, exp. date 09 2020 N17445N, exp. date 02 2020 P11326AA, exp. date 02 2021 P11326C, exp. date 02 2021 P13209L, exp. date 04 2021 P13212H, exp. date 06 2021 P13755A, exp. date 06 2021 P13756P, exp. date 08 2021 R11845A, exp. date 04 2022 R13271A, exp. date 04 2022 R13648A, exp. date 06 2022 R14101A, exp. date 07 2022 R14667A, exp. date 08 2022 R15953C, exp. date 09 2022
Why it was recalled
Superpotent Drug
Recalling firm
- Firm
- Ferring Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1149
Distribution
- Quantity
- 29,371 nasal sprays
- Distribution pattern
- Nationwide within the United States.
Timeline
- Recall initiated
- 2020-07-21
- FDA classified
- 2020-08-17
- Posted by FDA
- 2020-08-26
- Terminated
- 2023-10-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1506-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.