PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: August 26, 2015 Initiated: August 13, 2015 #D-1350-2015

Product Description

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

Reason for Recall

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

Details

Units Affected
360 Bottles
Distribution
U.S. Including: OH
Location
Huntsville, AL

Frequently Asked Questions

What product was recalled?
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. Recalled by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals. Units affected: 360 Bottles.
Why was this product recalled?
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 26, 2015. Severity: Low. Recall number: D-1350-2015.