Fluoxetine Capsule
FDA Recall NDC 50111-648
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Fluoxetine (NDC 50111-648). A significant event, classified as Class II, was initiated on Apr 13, 2015 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Apr 13, 2015
May 06, 2015
N/A
Recall Profile & Regulatory Data
Event ID
70976
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 27, 2016
Product Description
Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960
Batch or Lot Expiration Information
Lot# : a) 6A208123, Exp 8/2015; b) 6A208121, Exp 8/2015.
Affected Packages Involved in this Recall
50111-647-01Product
50111-647-02Product
50111-647-03Product
50111-648-01Product
50111-648-02Product
50111-648-03Product
50111-648-44Product
Class II Terminated
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.
Apr 13, 2015
May 06, 2015
N/A
Recall Profile & Regulatory Data
Event ID
70976
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 27, 2016
Product Description
Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01
Batch or Lot Expiration Information
Lot# : 6A207012, Exp 7/2015.
Affected Packages Involved in this Recall
50111-647-01Product
50111-647-02Product
50111-647-03Product
50111-648-01Product
50111-648-02Product
50111-648-03Product
50111-648-44Product
Class II Terminated
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Feb 12, 2014
May 07, 2014
257904 bottles
Recall Profile & Regulatory Data
Event ID
67563
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Dec 15, 2014
Product Description
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, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
50111-647-01Product
50111-647-02Product
50111-647-03Product
50111-648-01Product
50111-648-02Product
50111-648-03Product
50111-648-44Product
Class II Terminated
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Feb 12, 2014
May 07, 2014
72,356 bottles
Recall Profile & Regulatory Data
Event ID
67563
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Dec 15, 2014
Product Description
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-647-01, UPC 3 50111-647-01 5.
Batch or Lot Expiration Information
Lot# : 6A211158, 6A211159, 6A211163, Exp 11/15
Affected Packages Involved in this Recall
50111-647-01Product
50111-647-02Product
50111-647-03Product
50111-648-01Product
50111-648-02Product
50111-648-03Product
50111-648-44Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
