Recalls / Class III
Class IIID-1045-2016
Product
Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01
- Affected lot / code info
- Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Recalling firm
- Firm
- Sandoz, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr Ste 400, N/A, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 78,606 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-02
- FDA classified
- 2016-06-20
- Posted by FDA
- 2016-06-29
- Terminated
- 2017-08-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1045-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.