Why it was recalled
Lack of Assurance of Sterility
Product description
Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable 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: 04142016@75, 04252016@52, 05042016@143, 05042016@158, 06092016@169, 06242016@158, 08022016@154, 08112016@56, 08252016@82, 09082016@41. Known vial lot code: 04062016@7, 04182016@49, 04292016@80, 04282016@43, 06012016@44, 06152016@57, 07132016@68, 08042016@35, 08192016@45, 08242016@33
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-0348-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2016
- FDA report date
- Jan 11, 2017
- Quantity
- 5277 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-0348-2017, 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: 04142016@75, 04252016@52, 05042016@143, 05042016@158, 06092016@169, 06242016@158, 08022016@154, 08112016@56, 08252016@82, 09082016@41. Known vial lot code: 04062016@7, 04182016@49, 04292016@80, 04282016@43, 06012016@44, 06152016@57, 07132016@68, 08042016@35, 08192016@45, 08242016@33
- Postal code
- 34474-2853
- Report date
- Jan 11, 2017
- Product type
- Drugs
- Recall number
- D-0348-2017
- Classification
- Class II
- Recalling firm
- Wells Pharmacy Network LLC
- Product quantity
- 5277 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
- Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable 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