April 2017 FDA Recall Amoxicillin And Clavulanate Potassium by Sandoz Inc
D-0868-2017 - Subpotent Drug; Clavulanic Acid
This Class III drug recall was voluntarily initiated by Sandoz Inc on April 26, 2017 for the product Amoxicillin And Clavulanate Potassium. The FDA reported the reason for recall as subpotent drug; clavulanic acid. The product was distributed in NY, OH and the recall is currently terminated.
Recall Number: D-0868-2017
Subpotent Drug; Clavulanic Acid
04-26-2017
06-07-2017
4,464 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sandoz Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NY, OH
08-19-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20
Batch or Lot Expiration Information
Lot# Lot FP8735, 8/2017
