Recall: D-1260-2020

Class II - Potentially Harmful

Class IIClassification

2020-03-05Initiated

TerminatedStatus

Teva Pharmaceuticals USAFirm

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

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

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.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.