Why it was recalled
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Product description
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35.
Lot numbers, UPCs & expiration codes
Lot # 1811195, Exp. Date: 05/01/19
Where it was sold
CA, AZ, MI, NY
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-0518-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 19, 2019
- FDA report date
- Mar 13, 2019
- Quantity
- 569 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Leiter's Enterprises, Inc.
Original FDA data
Every field from FDA enforcement report D-0518-2019, exactly as published.
Show all FDA fields
- City
- San Jose
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 82229
- Address
- 17 Great Oaks Blvd
- Code information
- Lot # 1811195, Exp. Date: 05/01/19
- Postal code
- 95119-1359
- Report date
- Mar 13, 2019
- Product type
- Drugs
- Recall number
- D-0518-2019
- Classification
- Class II
- Recalling firm
- Leiter's Enterprises, Inc.
- Product quantity
- 569 vials
- Termination date
- Feb 26, 2020
- Reason for recall
- Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35.
- Distribution pattern
- CA, AZ, MI, NY
- Recall initiation date
- Feb 19, 2019
- Initial firm notification
- Telephone
- Center classification date
- Mar 6, 2019