FDARecalled Jan 1, 2025 · #D-0165-2025
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Alle...
Hazard
Class II — temporary health risk
Be the first to hear about future recalls.
Add the things you own to a watchlist. We’ll alert you the moment one matches.
Get started, freeDescription
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. Classification: Class II Distribution: Nationwide in the US
Product details
- Product
- Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
- Type
- Drugs
- Manufacturer
- RemedyRepack Inc.
- Model numbers
- 70518-0937-04, 70518-0937-03, J0786744-061724, B3002625-060524
- UPCs
- —