Duloxetine Delayed-Release Capsules Recalled Due to Manufacturing Quality Deviation
Amerisource Health Services LLC recalls Duloxetine 20 mg delayed-release capsules due to the presence of N-nitroso-duloxetine impurity above acceptable limits. The affected bottles were distributed in Pennsylvania, Ohio, and Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall without reported hospitalizations, illnesses, or injuries. The recall involves a manufacturing quality deviation where an impurity exceeded acceptable limits, representing a risk-of-harm situation with no actual patient harm yet reported. Per the rubric, this qualifies as High (Score 3).
Plain-English summary
Duloxetine 20 mg delayed-release capsules manufactured by Aurobindo Pharma Limited for BluePoint Laboratories are being recalled by Amerisource Health Services LLC due to a manufacturing quality deviation. The recall affects 37,916 bottles across lots DT2023001A and DT2023009A with an expiration date of January 31, 2025.
The reason for the recall is the presence of N-nitroso-duloxetine impurity above the recommended interim limit. This impurity resulted from a deviation in current good manufacturing practice (CGMP) and was identified during quality control review.
The affected capsules were distributed to Pennsylvania, Ohio, and Puerto Rico. Duloxetine is a prescription medication commonly used to treat depression, anxiety, and certain chronic pain conditions.
Patients currently taking this medication should consult their healthcare provider or pharmacist about whether their supply is affected and whether they should continue using it. Healthcare providers and pharmacies should identify and quarantine affected inventory and follow the recalling firm's instructions for return.
The recalled product
- Product
- Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Prescription Medication
- Hazard
- manufacturing-contamination
- impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots: DT2023001A
- DT2023009A
- exp date Jan 31
- 2025
Distribution
Distributed in 3 states:
- OH
- PA
- PR
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