FDAClass IIMay 13, 2020

Epinephrine Injection USP recall: CGMP Deviations

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…

Why was Epinephrine Injection USP recalled?

CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 007F19AA, exp. date 04/2021

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…
Recalling firm
Teva Pharmaceuticals USA
Quantity
600 cartons/2 auto-injector per carton
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.
Recall date
May 13, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls