FDARecalled May 13, 2026 · #D-0522-2026
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berk...
Hazard
Class II — temporary health risk
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CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Classification: Class II Distribution: Nationwide in the USA
Product details
- Product
- Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
- Type
- Drugs
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Model numbers
- 241069C
- UPCs
- —