Drug 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.
D-1179-2017
Product summary
- Firm
- Sandoz Inc
- Event
- Event 78169
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,435 shrink wrap packs
- Official record key
drug-enforcement:D-1179-2017
Official wording
Reason: Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Code information: Lot: GH8254, Exp 06/19
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Missing