FDA-Drug2015-08-26Class III

AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Hazard

Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.

Sold states
U.S. Including: OH
Affected count
360 Bottles
Manufactured in
150 Vintage Dr NE, Huntsville, AL, United States
Products
AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1350-2015

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