August 2015 FDA Recall Drug by Vintage Pharmaceuticals Llc, Dba Qualitest Pharmaceuticals
D-1350-2015 - Labeling
This Class III drug recall was voluntarily initiated by Vintage Pharmaceuticals Llc, Dba Qualitest Pharmaceuticals on August 13, 2015 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in U.S. Including: OH and the recall is currently terminated.
Recall Number: D-1350-2015
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
08-13-2015
08-26-2015
360 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Including: OH
08-21-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 52217, Expiry: 04/18
