April 2019 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1205-2019 - Subpotent Product

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on April 12, 2019 for the product Drug. The FDA reported the reason for recall as subpotent product. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1205-2019

Reason for Recall
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Initiated
04-12-2019
Reported
04-24-2019
Quantity
171,488 150 mL and 80 mL bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82619
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.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-08-2020
Product Description About Product Description
Full technical description of the product.
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# Lots: (a)
Lot# 35436769A, exp. date 05/2019; 35438389A, 35438390A, exp. date 01/2020; 35440838A, exp. date 10/2020; (b) 35437491A, 35443574B, exp. date 09/2021