FDA Recall D-0168-2021
AVKARE Inc. · Pulaski, TN
Class I — life-threatening Terminated 1043 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-0168-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the U.S.
- Recall initiated
- 2020-12-07
- Classified by FDA Center
- 2020-12-16
- FDA published
- 2020-12-23
- Terminated
- 2023-10-16
- Recalling firm
- AVKARE Inc.
- Firm location
- Pulaski, TN