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

Recalled May 29, 2024 · FDA recall D-0505-2024 · Preferred Pharmaceuticals

Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit · FDA Class II
Units
66 bottles of 30 tablets
Sold at
Product distributed to CA, FL, OK, KS and CT

Description

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

Product
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Manufacturer(s)
Preferred Pharmaceuticals, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

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