September 2020 FDA Recall Buprenorphine by Teva Pharmaceuticals Usa
D-0003-2021 - Failed Stability Specifications
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on September 4, 2020 for the product Buprenorphine. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0003-2021
Failed Stability Specifications: Below specification result for buprenorphine release rate.
09-04-2020
10-07-2020
32,543 cartons
Recall Profile & Regulatory Data
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.
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 U.S. and PR
08-26-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
Batch or Lot Expiration Information
Lot# 190017, exp. 02/2021; 190161, exp. 08/2021
