Recalls / Class II
Class IID-0505-2024
Product
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
- Affected lot / code info
- Lot #: J2022G, Exp: 01/01/2025
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 66 bottles of 30 tablets
- Distribution pattern
- Product distributed to CA, FL, OK, KS and CT
Timeline
- Recall initiated
- 2024-05-10
- FDA classified
- 2024-05-21
- Posted by FDA
- 2024-05-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0505-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.