D-0291-2015 Class III Terminated
FDA drug recall D-0291-2015 was initiated by Sandoz Incorporated on December 5, 2014 and is designated Class III. Reason for recall: Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule. The recall status is terminated (terminated June 24, 2015). Affected quantity: 1,008 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 17, 2014
- Initiation Date
- December 5, 2014
- Termination Date
- June 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,008 bottles
Product Description
Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
Reason for Recall
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Distribution Pattern
AZ
Code Information
Lot ET5122, Exp. 10/17