March 2020 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1260-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on March 5, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product. and the recall is currently terminated.

Recall Number: D-1260-2020

Reason for Recall
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Initiated
03-05-2020
Reported
05-13-2020
Quantity
600 cartons/2 auto-injector per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85146
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.
Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-19-2020
Product Description About Product Description
Full technical description of the product.
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27

Batch or Lot Expiration Information

Lot# 007F19AA, exp. date 04/2021

Affected Packages Involved in this Recall

0093-5986-19 Epinephrine
0093-5986-27 Epinephrine
0093-5985-19 Epinephrine
0093-5985-27 Epinephrine