June 2016 FDA Recall Drug by Teva North America
D-1455-2016 - Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.

This Class II drug recall was voluntarily initiated by Teva North America on June 22, 2016 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1455-2016

Reason for Recall
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Initiated
06-22-2016
Reported
08-17-2016
Quantity
8,052 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74502
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 North America
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2017
Product Description About Product Description
Full technical description of the product.
Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16

Batch or Lot Expiration Information

Lot# 95113, exp 01/2017