D-0168-2021 Class I Terminated
FDA drug recall D-0168-2021 was initiated by AVKARE Inc. on December 7, 2020 and is designated Class I. Reason for recall: Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. The recall status is terminated (terminated October 16, 2023). Affected quantity: 14368 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 23, 2020
- Initiation Date
- December 7, 2020
- Termination Date
- October 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14368 bottles
Product Description
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
Reason for Recall
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Distribution Pattern
Nationwide within the U.S.
Code Information
Lot: 36783 Exp. 06/2022