Recalls / Class II
Class IID-0085-2018
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
- Brand name
- Lorazepam
- Generic name
- Lorazepam
- Active ingredient
- Lorazepam
- Route
- Oral
- NDCs
- 69315-904, 69315-905, 69315-906
- FDA application
- ANDA078203
- Affected lot / code info
- Lot #E00717
Why it was recalled
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Recalling firm
- Firm
- Leading Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Oak Rd, N/A, Fairfield, New Jersey 07004-2903
Distribution
- Quantity
- 2952 500-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-09-28
- FDA classified
- 2017-11-20
- Posted by FDA
- 2017-11-29
- Terminated
- 2020-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0085-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.