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
Product summary
- 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
CGMP Deviations
-
Potency or specification failure
Out-of-specification