D-1260-2020 Class II Terminated
FDA drug recall D-1260-2020 was initiated by Teva Pharmaceuticals USA on March 5, 2020 and is designated Class II. 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. The recall status is terminated (terminated November 19, 2020). Affected quantity: 600 cartons/2 auto-injector per carton.
Recall Details
- Product Type
- Drugs
- Report Date
- May 13, 2020
- Initiation Date
- March 5, 2020
- Termination Date
- November 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 600 cartons/2 auto-injector per carton
Product Description
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 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.
Code Information
Lot # 007F19AA, exp. date 04/2021