Sandoz Inc recalls Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (…

Recall date

September 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1179-2017

FDA classification

Class III

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.