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

FDA recall notice · announced June 29, 2016 · Sandoz

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

Notes

Distribution: Nationwide
Lot/code information: Lot #: EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017
Quantity: N/A
Status: Terminated
Products in this recall event:
- 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 (D-1045-2016)
- 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 (D-1046-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.