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, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
Lot numbers, UPCs & expiration codes
Lot #: EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017
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-1046-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 2, 2016
- FDA report date
- Jun 29, 2016
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz, Inc
Original FDA data
Every field from FDA enforcement report D-1046-2016, 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 #: EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017
- Postal code
- 08540-6243
- Report date
- Jun 29, 2016
- Product type
- Drugs
- Recall number
- D-1046-2016
- Classification
- Class III
- Recalling firm
- Sandoz, Inc
- 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, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
- Distribution pattern
- Nationwide
- Recall initiation date
- May 2, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 20, 2016