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.

FDA recall notice · announced October 4, 2017 · Sandoz

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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.

Reason for recall

Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot: GH8254, Exp 06/19
Quantity: 13,435 shrink wrap packs
Status: Terminated
Products in this recall event:
- 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. (D-1179-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.