Teva Pharmaceuticals USA: Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d)

Is my product affected?

Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow,

• Brand FLUOXETINE

Check against the official notice below — it lists the full affected range.

What happened

Teva Pharmaceuticals USA is recalling Fluoxetine Capsules USP, 20 mg, distributed nationwide and in Puerto Rico due to chemical contamination indicated by customer complaints about capsule odor. The recall affects 257,904 bottles across multiple package sizes: 100-count bottles (NDC 50111-648-01), 500-count bottles (NDC 50111-648-02), 1000-count bottles (NDC 50111-648-03), and an additional package size. The affected lots include specific lot numbers with expiration dates ranging from September 2015 through December 2015.

The source document does not specify a remedy or corrective action that consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

Details from the source

Reason for recall: Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor. Distribution: Nationwide and Puerto Rico Quantity: 257904 bottles Lot/code info: 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 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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