Recalls / Class III

Class IIID-1350-2015

Product

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

Affected lot / code info

Lot #: 52217, Expiry: 04/18

Why it was recalled

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

Recalling firm

Firm

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

150 Vintage Dr NE, Huntsville, Alabama 35811-8216

Distribution

Quantity

360 Bottles

Distribution pattern

U.S. Including: OH

Timeline

Recall initiated

2015-08-13

FDA classified

2015-08-20

Posted by FDA

2015-08-26

Terminated

2015-08-21

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1350-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.