D-0505-2024 Class II Ongoing
FDA drug recall D-0505-2024 was initiated by Preferred Pharmaceuticals, Inc. on May 10, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit The recall status is ongoing. Affected quantity: 66 bottles of 30 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2024
- Initiation Date
- May 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 bottles of 30 tablets
Product Description
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution Pattern
Product distributed to CA, FL, OK, KS and CT
Code Information
Lot #: J2022G, Exp: 01/01/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0505-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026