Recalls / Class I
Class ID-1505-2020
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
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
- Affected lot / code info
- 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
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
- 184,325 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-1505-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.