Class III
Terminated
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.
This recall has been terminated (originally issued October 4, 2017).
- Company
- Sandoz Inc
- Recall Initiated
- September 25, 2017
- Posted
- October 4, 2017
- Recall Number
- D-1179-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,435 shrink wrap packs
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot: GH8254, Exp 06/19
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