NDC 0615-8093
Fluoxetine 10 mg capsule
On the label: NCS HealthCare of KY, Inc dba Vangard Labs. It's repackaged: NCS HealthCare of KY, Inc dba Vangard Labs rebottles it from Teva Pharmaceuticals USA, Inc.'s NDC 50111-647.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Teva Pharmaceuticals USA, Inc. names for other drugs.
Repackaging site
- NCS HealthCare of KY, LLC dba Vangard Labs, Glasgow, KY, United States · repackages it
Recalls
- Apr 13, 2015 · Class II · Teva Pharmaceuticals USA
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Lots: Lot #: 6A207012, Exp 7/2015. - Apr 13, 2015 · Class II · Teva Pharmaceuticals USA
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Lots: Lot #: a) 6A208123, Exp 8/2015; b) 6A208121, Exp 8/2015. - Feb 12, 2014 · Class II · Teva Pharmaceuticals USA
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Lots: Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/1… - Feb 12, 2014 · Class II · Teva Pharmaceuticals USA
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Lots: Lot #: 6A211158, 6A211159, 6A211163, Exp 11/15
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluoxetine: every company that makes it
- Form
- capsule, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA076001
- On the market since
- Jan 29, 2002
- Package NDCs
0615-8093-39- Official label
- DailyMed (National Library of Medicine), updated Jul 30, 2025
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