D-0085-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2017
- Initiation Date
- September 28, 2017
- Termination Date
- September 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2952 500-count bottles
Product Description
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
Reason for Recall
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Distribution Pattern
Nationwide in the USA
Code Information
Lot #E00717