Recalling firm
Rising Pharma Holding, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-03-26
Distribution
Nationwide in the USA.
Firm state
NJ
Product quantity
1223 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product description
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Code / lot info
Lot #: DTB23111A, Exp 8/31/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.