Recalls / Class I
Class ID-0630-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot #: 2190A, 2191A, Exp. Date 07/2021
Why it was recalled
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Recalling firm
- Firm
- Lannett Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9000 State Rd, Philadelphia, Pennsylvania 19136-1615
Distribution
- Quantity
- 16,668 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-12-06
- FDA classified
- 2019-12-27
- Posted by FDA
- 2019-12-25
- Terminated
- 2020-07-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0630-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.