Drug recalls

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

Preferred Pharmaceuticals, Inc. · CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIOngoingD-0505-2024
Status
Ongoing
City
Anaheim
State
CA
Country
United States
Classification
Class II
Product type
Drugs
Event ID
94648
Recalling firm
Preferred Pharmaceuticals, Inc.
Address 1
1250 N Lakeview Ave Ste O
Postal code
92807-1801
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
Product distributed to CA, FL, OK, KS and CT
Recall number
D-0505-2024
Product description
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Product quantity
66 bottles of 30 tablets
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiation date
20240510
Center classification date
20240521
Report date
20240529
Code info
Lot #: J2022G, Exp: 01/01/2025
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.