Recalls / Class I
Class ID-1504-2020
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
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
- Affected lot / code info
- 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
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
- 15,175 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-1504-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.