Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
National Drug Code
Is NDC 82009-0032-10 recalled?
Duloxetine · 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-032-10)
Yes — this exact package was recalled
2 FDA recalls name the code 82009-0032-10 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
2 of these recalls are still ongoing.
- Active ingredient
- Duloxetine Hydrochloride
- Strength
- DULOXETINE HYDROCHLORIDE 60 mg/1
- Form
- Capsule, Delayed Release Pellets · Oral
- Labeler
- Quallent Pharmaceuticals Health, LLC
- Type
- Human Prescription Drug
- Product code
- 82009-0032
Recalls naming this package
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 82009-0022 Omeprazole 1
- 82009-0030 Duloxetine 1
- 82009-0117 Metformin ER 500 mg 1
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