Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

FDA recall notice · announced May 29, 2024 · Preferred Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Notes

Distribution: Product distributed to CA, FL, OK, KS and CT
Lot/code information: Lot #: J2022G, Exp: 01/01/2025
Quantity: 66 bottles of 30 tablets
Status: Ongoing
Products in this recall event:
- Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03 (D-0505-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.