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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