Why it was recalled
Lack of Assurance of Sterility
Product description
Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
Lot numbers, UPCs & expiration codes
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04112016@201, 04202016@33, 05182016@46, 05232016@227, 06072016@55, 06092016@88, 06142016@60, 07012016@112, 07132016@142, 07292016@121, 07292016@129. Known vial lot code: 04062016@106, 04182016@10, 04262016@56, 05022016@189, 05102016@54, 05192016@84, 05242016@135, 06232016@70, 07012016@112, 07072016@94.
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-0380-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2016
- FDA report date
- Jan 11, 2017
- Quantity
- 2,336 kits (number of vials per kit vary by prescription)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wells Pharmacy Network LLC
Original FDA data
Every field from FDA enforcement report D-0380-2017, exactly as published.
Show all FDA fields
- City
- Ocala
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 75289
- Address
- 1210 SW 33rd Ave
- Code information
- All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04112016@201, 04202016@33, 05182016@46, 05232016@227, 06072016@55, 06092016@88, 06142016@60, 07012016@112, 07132016@142, 07292016@121, 07292016@129. Known vial lot code: 04062016@106, 04182016@10, 04262016@56, 05022016@189, 05102016@54, 05192016@84, 05242016@135, 06232016@70, 07012016@112, 07072016@94.
- Postal code
- 34474-2853
- Report date
- Jan 11, 2017
- Product type
- Drugs
- Recall number
- D-0380-2017
- Classification
- Class II
- Recalling firm
- Wells Pharmacy Network LLC
- Product quantity
- 2,336 kits (number of vials per kit vary by prescription)
- Termination date
- Jul 2, 2021
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 21, 2016
- Initial firm notification
- Press Release
- Center classification date
- Jan 4, 2017