Why it was recalled
Labeling: Label Error on Declared Strength
Product description
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
Lot numbers, UPCs & expiration codes
Lot: MIT100217SVDS BUD: 03/01/2018
Where it was sold
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-0251-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 11, 2018
- FDA report date
- Feb 7, 2018
- Quantity
- 193 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Premier Pharmacy Labs Inc
Original FDA data
Every field from FDA enforcement report D-0251-2018, exactly as published.
Show all FDA fields
- City
- Weeki Wachee
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 78928
- Address
- 8265 Commercial Way
- Code information
- Lot: MIT100217SVDS BUD: 03/01/2018
- Postal code
- 34613-4511
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0251-2018
- Classification
- Class II
- Recalling firm
- Premier Pharmacy Labs Inc
- Product quantity
- 193 vials
- Termination date
- Jun 4, 2020
- Reason for recall
- Labeling: Label Error on Declared Strength
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jan 11, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 2, 2018