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
Check against the official notice below — it lists the full affected range.
Teva Pharmaceuticals USA is recalling Epinephrine Injection USP 0.3 mg auto-injectors due to manufacturing quality deviations. A non-marketed lot number that shared the same component was found to have out-of-specification trigger force, prompting precautionary measures. The affected lot is #007F19AA with an expiration date of 04/2021, consisting of 600 cartons containing 2 auto-injectors per carton.
The product was distributed to only one wholesaler, who retained all units and did not ship or distribute any of the product further. The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
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. Quantity: 600 cartons/2 auto-injector per carton Lot/code info: Lot # 007F19AA, exp. date 04/2021
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.