Recalls / Class II
Class IID-0330-2017
Product
QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
- Affected lot / code info
- All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03292016@12, 0422016@10, 04222016@10, 05052016@33, 05122016@11, 05132016@19, 05242016@2, 06212016@17, 07262016@36, 09072016@21, 09142015@17 b) Known lot code: 03242016@9, 04112016@10, 04212016@19, 05042016@20, 05132016@21, 05202016@71, 06152016@7, 07122016@21, 08032016@17, 09092016@35.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Wells Pharmacy Network LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1210 SW 33rd Ave, N/A, Ocala, Florida 34474-2853
Distribution
- Quantity
- a) 1,312 vials and b) 3,354 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-21
- FDA classified
- 2017-01-04
- Posted by FDA
- 2017-01-11
- Terminated
- 2021-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0330-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.