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FDARecalled May 29, 2024 · #D-0505-2024

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

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Classification: Class II Distribution: Product distributed to CA, FL, OK, KS and CT

Product details

Product
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Type
Drugs
Manufacturer
Preferred Pharmaceuticals, Inc.
Model numbers
J2022G
UPCs