Class II ยท Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
National Drug Code
Is NDC 27241-0098-10 recalled?
Duloxetine · 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-098-10)
Yes — this exact package was recalled
1 FDA recall names the code 27241-0098-10 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.
1 of these recalls is still ongoing.
- Active ingredient
- Duloxetine
- Strength
- DULOXETINE HYDROCHLORIDE 30 mg/1
- Form
- Capsule, Delayed Release · Oral
- Labeler
- Ajanta Pharma USA Inc.
- Type
- Human Prescription Drug
- Product code
- 27241-0098
Recalls naming this package
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
- 27241-0056 Aripiprazole 1
- 27241-0097 Duloxetine 1
- 27241-0099 Duloxetine 1
- 27241-0118 Fenofibrate 1
- 27241-0120 Fenofibrate 1
- 27241-0255 Fluphenazine hydrochloride 1
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