Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
Reported: November 29, 2017 Initiated: September 28, 2017 #D-0085-2018
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
Details
- Recalling Firm
- Leading Pharma, LLC
- Units Affected
- 2952 500-count bottles
- Distribution
- Nationwide in the USA
- Location
- Fairfield, NJ
Frequently Asked Questions
What product was recalled? ▼
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05. Recalled by Leading Pharma, LLC. Units affected: 2952 500-count bottles.
Why was this product recalled? ▼
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 29, 2017. Severity: Moderate. Recall number: D-0085-2018.
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