Published recall report · ImpurityUpdated · 1 yr 8 mo ago
Rising Pharma Holding, Inc. recall: Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
- Producer
- Rising Pharma Holding, Inc.
DT2023003A
- Dates on pack
- Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
More detail
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
In the news
Reporting from news publishers. Follow the official notice for product advice.
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