Multi-event July 2020 FDA Recall Drug by Ferring Pharmaceuticals Inc
This Multi-event Class I drug recall was voluntarily initiated by Ferring Pharmaceuticals Inc on July 21, 2020 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1505-2020
Superpotent Drug
07-21-2020
08-26-2020
184,325 nasal sprays
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ferring Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States.
10-13-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05
Batch or Lot Expiration Information
Lot# : N14695P, N14695S, exp. date 08 2020; N15627G , exp. date 10 2020 N15627GA, exp. date 10 2020 P10422A, exp. date 01 2021 P10422AA, exp. date 01 2021 P10430G, exp. date 03 2021 P11319M, exp. date 01 2021 P12969H, exp. date 05 2021 P12969IR, exp. date 05 2021 P13216G, exp. date 05 2021 P13216P, exp. date 05 2021 R11842A, exp. date 03 2022 R11842S, exp. date 03 2022 R12630A, exp. date 05 2022 R13071H, exp. date 04 2022
Recall Number: D-1504-2020
Superpotent Drug
07-21-2020
08-26-2020
15,175 nasal sprays
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ferring Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States.
10-13-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0
Batch or Lot Expiration Information
Lot# : N14695F, exp. date 08/2020 N15627C, exp. date 10/2020 P11319P, exp. date 01/2021 P11706F, exp. date 04/2021 R11842C, exp. date 03/2022; R13637E, exp. date 06/2022
Recall Number: D-1506-2020
Superpotent Drug
07-21-2020
08-26-2020
29,371 nasal sprays
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ferring Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States.
10-13-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
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
