Class II

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

Preferred Pharmaceuticals, Inc. · May 10, 2024

Reason for Recall

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

Distribution

Product distributed to CA, FL, OK, KS and CT

States Affected

CA, CT, FL, KS, OK

Quantity Affected

66 bottles of 30 tablets

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0505-2024

Status: ongoing

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