Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Product description
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
Lot numbers, UPCs & expiration codes
Lot: 03022020@5 BUD: 03/16/2020
Where it was sold
Specific prescriptions to patients in TN
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-1077-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 13, 2020
- FDA report date
- Apr 8, 2020
- Quantity
- 2 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medical Center Pharmacy, Inc.
Original FDA data
Every field from FDA enforcement report D-1077-2020, exactly as published.
Show all FDA fields
- City
- Cleveland
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 85217
- Address
- 2401 N Ocoee St
- Code information
- Lot: 03022020@5 BUD: 03/16/2020
- Postal code
- 37311-3853
- Report date
- Apr 8, 2020
- Product type
- Drugs
- Recall number
- D-1077-2020
- Classification
- Class II
- Recalling firm
- Medical Center Pharmacy, Inc.
- Product quantity
- 2 bottles
- Termination date
- Oct 14, 2022
- Reason for recall
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
- Distribution pattern
- Specific prescriptions to patients in TN
- Recall initiation date
- Mar 13, 2020
- Initial firm notification
- Telephone
- Center classification date
- Apr 1, 2020