September 2017 FDA Recall Ampicillin by Sandoz Inc
D-1179-2017 - Labeling
This Class III drug recall was voluntarily initiated by Sandoz Inc on September 25, 2017 for the product Ampicillin. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1179-2017
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
09-25-2017
10-04-2017
13,435 shrink wrap packs
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.
Nationwide in the USA and Puerto Rico
04-08-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
Batch or Lot Expiration Information
Lot# Lot: GH8254, Exp 06/19
