Why it was recalled
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Product description
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
Lot numbers, UPCs & expiration codes
Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022
Where it was sold
U.S.A. Nationwide
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-0519-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 11, 2019
- FDA report date
- Nov 27, 2019
- Quantity
- 25120 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- X-Gen Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0519-2020, exactly as published.
Show all FDA fields
- City
- Horseheads
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84027
- Address
- 300 Daniel Zenker Dr
- Code information
- Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022
- Postal code
- 14845-1014
- Report date
- Nov 27, 2019
- Product type
- Drugs
- Recall number
- D-0519-2020
- Classification
- Class III
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Product quantity
- 25120 vials
- Termination date
- Aug 16, 2022
- Reason for recall
- Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Oct 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2019