Multi-event June 2017 FDA Recall Drug by Teva Pharmaceuticals Usa
This Multi-event Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on June 29, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0983-2017
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
06-29-2017
07-26-2017
25264 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
04-26-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
Batch or Lot Expiration Information
Lot# : 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018
Recall Number: D-0984-2017
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
06-29-2017
07-26-2017
196275 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
04-26-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
Batch or Lot Expiration Information
Lot# : 30227649A ,30227650A, 30227651A, 30227652A, 30227653A, 30227654A, 30227655A, 30227832A, 30227833A, 30227834A, 30227835A, EXP 06/2017; 30228561A, 30228562A, 30228563A, 30228564A, 30228565A, 30228566A, 30228567A, 30228568A, 30228569A, 30228570A, EXP 9/2017; 3000124, 3000125, EXP 7/2018; 3000392, 3000393, 3000394, EXP 9/2018; 3000872, 3000874, EXP 10/2018
