July 2018 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1074-2018 - API material used in the manufacturing of the product did not receive regulatory approval prior to release.

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on July 16, 2018 for the product Drug. The FDA reported the reason for recall as api material used in the manufacturing of the product did not receive regulatory approval prior to release.. The product was distributed in Product was distributed throughout the United States and the recall is currently terminated.

Recall Number: D-1074-2018

Reason for Recall
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Initiated
07-16-2018
Reported
08-15-2018
Quantity
13,715 120-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80550
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-28-2019
Product Description About Product Description
Full technical description of the product.
Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89

Batch or Lot Expiration Information

Lot# 150001420A, EXP 2/2019