Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Reported: May 29, 2024 Initiated: May 10, 2024 #D-0505-2024
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
Details
- Recalling Firm
- Preferred Pharmaceuticals, Inc.
- Units Affected
- 66 bottles of 30 tablets
- Distribution
- Product distributed to CA, FL, OK, KS and CT
- Location
- Anaheim, CA
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: 66 bottles of 30 tablets.
Why was this product recalled? ▼
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 29, 2024. Severity: Moderate. Recall number: D-0505-2024.
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