December 2016 FDA Recall Drug by Teva Pharmaceuticals Usa
D-0440-2017 - Subpotency

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on December 21, 2016 for the product Drug. The FDA reported the reason for recall as subpotency. The product was distributed in United States and Puerto Rico and the recall is currently terminated.

Recall Number: D-0440-2017

Reason for Recall
Subpotency: due to a low, out of specification test result for assay during stability testing.
Initiated
12-21-2016
Reported
02-01-2017
Quantity
133,601 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76038
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.
United States and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-06-2018
Product Description About Product Description
Full technical description of the product.
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73

Batch or Lot Expiration Information

Lot# 35432507A, 35434914A, 35435798A, 35437490A, Exp 9/19