NDC 53217-155

Fluoxetine 20 mg capsule

On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Teva Pharmaceuticals USA, Inc.'s NDC 50111-648.

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.

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.

Generic drug: Fluoxetine: every company that makes it
Form: capsule
Strength: 20 mg
Approval: ANDA ANDA076001
On the market since: Jan 29, 2002
Package NDCs: 53217-155-30 53217-155-60 53217-155-90
Official label: DailyMed (National Library of Medicine), updated Feb 17, 2017

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