Drug 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
D-0630-2020
Product summary
- Event
- Event 84427
- Status
- Terminated
- Classification
- Class I
- Quantity
- 16,668 bottles
- Official record key
drug-enforcement:D-0630-2020
Official wording
Reason: Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Code information: Lot #: 2190A, 2191A, Exp. Date 07/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Microbial contamination
Microbial Contamination
-
Potency or specification failure
Out-of-specification