FDA-Drug2020-05-13Class II
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
Teva Pharmaceuticals USA
Hazard
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Sold states
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.
Affected count
600 cartons/2 auto-injector per carton
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1260-2020Don't want to check this manually?
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