Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05

FDA recall notice · announced November 29, 2017 · Leading Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #E00717
Quantity: 2952 500-count bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.