Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1045-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 2, 2016
- FDA report date
- Jun 29, 2016
- Quantity
- 78,606 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz, Inc
Original FDA data
Every field from FDA enforcement report D-1045-2016, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74068
- Address
- 506 Carnegie Ctr Ste 400
- Code information
- Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017
- Postal code
- 08540-6243
- Report date
- Jun 29, 2016
- Product type
- Drugs
- Recall number
- D-1045-2016
- Classification
- Class III
- Recalling firm
- Sandoz, Inc
- Product quantity
- 78,606 bottles
- Termination date
- Aug 17, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- May 2, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 20, 2016