Recalls / Class II
Class IID-0221-2021
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
- Affected lot / code info
- Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022
Why it was recalled
Defective container: Customer complaints for oral solution leaking from bottles.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 22,248 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2020-12-28
- FDA classified
- 2021-01-11
- Posted by FDA
- 2021-01-20
- Terminated
- 2022-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0221-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.