Drug product
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
D-0085-2018
Product summary
- Event
- Event 78471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2952 500-count bottles
- Official record key
drug-enforcement:D-0085-2018
Official wording
Reason: Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Code information: Lot #E00717
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Label Error