Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product description
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Lot numbers, UPCs & expiration codes
Lot #: J2022G, Exp: 01/01/2025
Where it was sold
Product distributed to CA, FL, OK, KS and CT
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0505-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 10, 2024
- FDA report date
- May 29, 2024
- Quantity
- 66 bottles of 30 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0505-2024, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94648
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot #: J2022G, Exp: 01/01/2025
- Postal code
- 92807-1801
- Report date
- May 29, 2024
- Product type
- Drugs
- Recall number
- D-0505-2024
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 66 bottles of 30 tablets
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
- Distribution pattern
- Product distributed to CA, FL, OK, KS and CT
- Recall initiation date
- May 10, 2024
- Initial firm notification
- Letter
- Center classification date
- May 21, 2024