Recalls / Class III
Class IIID-0291-2015
Product
Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
- Affected lot / code info
- Lot ET5122, Exp. 10/17
Why it was recalled
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 1,008 bottles
- Distribution pattern
- AZ
Timeline
- Recall initiated
- 2014-12-05
- FDA classified
- 2014-12-09
- Posted by FDA
- 2014-12-17
- Terminated
- 2015-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0291-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.