D-1179-2017 Class III Terminated
FDA drug recall D-1179-2017 was initiated by Sandoz Inc on September 25, 2017 and is designated Class III. Reason for recall: Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels. The recall status is terminated (terminated April 8, 2019). Affected quantity: 13,435 shrink wrap packs.
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