FDA recall D-1260-2020

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.

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.

Key facts

Status

Terminated

Initiation date

2020-03-05

Report date

2020-05-13

Termination date

2020-11-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1260-2020