Published recall report · ImpurityUpdated · 1 yr 9 mo ago
Amerisource Health Services LLC recall: Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
- Producer
- Amerisource Health Services LLC
DT6022166A
- Dates on pack
- Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025
DT6023071A
- Dates on pack
- Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025
More detail
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
In the news
Reporting from news publishers. Follow the official notice for product advice.
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