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
Reported: December 25, 2019 Initiated: December 6, 2019 #D-0630-2020
Product Description
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.
Details
- Recalling Firm
- Lannett Company, Inc.
- Units Affected
- 16,668 bottles
- Distribution
- Nationwide within the United States
- Location
- Philadelphia, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lannett Company, Inc.. Units affected: 16,668 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 25, 2019. Severity: Critical. Recall number: D-0630-2020.
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