Dicloxacillin Sodium Capsules recall: Impurity Out of Spec
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
Why was Dicloxacillin Sodium Capsules recalled?
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017
- 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
- Recalling firm
- Sandoz, Inc
- Quantity
- 78,606 bottles
- Distribution
- Nationwide
- Recall date
- June 29, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)