Drug product
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
D-0221-2021
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 87051
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,248 bottles
- Official record key
drug-enforcement:D-0221-2021
Official wording
Reason: Defective container: Customer complaints for oral solution leaking from bottles.
Code information: Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Unknown
Defective container: Customer complaints for oral solution leaking from bottles.