D-1179-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 4, 2017
- Initiation Date
- September 25, 2017
- Termination Date
- April 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,435 shrink wrap packs
Product Description
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.
Reason for Recall
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot: GH8254, Exp 06/19