FDA Recall D-0630-2020
Lannett Company, Inc. · Philadelphia, PA
Class I — life-threatening Terminated 220 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
Reason for recall
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Recall record
- Recall number
D-0630-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2019-12-06
- Classified by FDA Center
- 2019-12-27
- FDA published
- 2019-12-25
- Terminated
- 2020-07-13
- Recalling firm
- Lannett Company, Inc.
- Firm location
- Philadelphia, PA