Why it was recalled
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
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
Lot numbers, UPCs & expiration codes
Lot #E00717
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0085-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 28, 2017
- FDA report date
- Nov 29, 2017
- Quantity
- 2952 500-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Leading Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0085-2018, exactly as published.
Show all FDA fields
- City
- Fairfield
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78471
- Address
- 3 Oak Rd
- Code information
- Lot #E00717
- Postal code
- 07004-2903
- Report date
- Nov 29, 2017
- Product type
- Drugs
- Recall number
- D-0085-2018
- Classification
- Class II
- Recalling firm
- Leading Pharma, LLC
- Product quantity
- 2952 500-count bottles
- Termination date
- Sep 21, 2020
- Reason for recall
- Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 28, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2017