Recall: D-1179-2017

Class III - Minor Violations

Class IIIClassification

2017-09-25Initiated

TerminatedStatus

Sandoz IncFirm

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

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.