June 2014 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1538-2014 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on June 5, 2014 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1538-2014

Reason for Recall
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Initiated
06-05-2014
Reported
08-20-2014
Quantity
3881bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68522
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-16-2014
Product Description About Product Description
Full technical description of the product.
Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10

Batch or Lot Expiration Information

Lot# lot 29C220, Exp. 11/15