Drug recall D-1260-2020

Class II Terminated reported May 13, 2020

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

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.

Lots and codes

Lot # 007F19AA, exp. date 04/2021

Recall details

Recalling firm
Teva Pharmaceuticals USA, Parsippany, NJ
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.
Type
Voluntary: Firm initiated
Recall initiated
March 5, 2020
Terminated
November 19, 2020

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