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Recall Observatory FDA recall evidence

Drug 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

D-1260-2020

March 05, 2020

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 85146
Status
Terminated
Classification
Class II
Quantity
600 cartons/2 auto-injector per carton
Official record key
drug-enforcement:D-1260-2020

Official wording

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

Code information: Lot # 007F19AA, exp. date 04/2021

Distribution pattern: 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.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations
  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out-of-specification