Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Product description
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Lot numbers, UPCs & expiration codes
a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
Where it was sold
PA, OH, PR
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-0100-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 14, 2024
- FDA report date
- Dec 11, 2024
- Quantity
- 23,490 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0100-2025, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 95849
- Address
- 2550 John Glenn Ave Ste A
- Code information
- a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
- Postal code
- 43217-1188
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0100-2025
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 23,490 bottles
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
- Distribution pattern
- PA, OH, PR
- Recall initiation date
- Nov 14, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 3, 2024