Why it was recalled
Lack of Assurance of Sterility
Product description
Chorionic Gonadotropin, Lyophilized, 7,500 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:04052016@14, 05162016@126, 06092016@173, 06202016@137, 08042016@97, 09132016@117. Known vial lot code: 03242016@31, 04262016@25, 06032016@44, 06202016@137, 07252016@56, 09092016@17.
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-0350-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2016
- FDA report date
- Jan 11, 2017
- Quantity
- 1,638 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-0350-2017, 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:04052016@14, 05162016@126, 06092016@173, 06202016@137, 08042016@97, 09132016@117. Known vial lot code: 03242016@31, 04262016@25, 06032016@44, 06202016@137, 07252016@56, 09092016@17.
- Postal code
- 34474-2853
- Report date
- Jan 11, 2017
- Product type
- Drugs
- Recall number
- D-0350-2017
- Classification
- Class II
- Recalling firm
- Wells Pharmacy Network LLC
- Product quantity
- 1,638 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, 7,500 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