Class II
Ongoing
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
- Company
- Preferred Pharmaceuticals, Inc.
- Recall Initiated
- May 10, 2024
- Posted
- May 29, 2024
- Recall Number
- D-0505-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 66 bottles of 30 tablets
- Firm Location
- Anaheim, CA, United States
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
Lot / Code Info
Lot #: J2022G, Exp: 01/01/2025
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