Recalls / Class II
Class IID-0383-2017
Product
QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 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: 04122016@17, 04142016@14, 05112016@23, 06072016@17, 06232016@13, 07122016@41, 08052016@12 b) Known lot code: 03242016@8, 04142016@15, 05032016@11, 05262016@12, 06242016@11, 07122016@42, 08052016@11.
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) 1,165 vials b) 2,217 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-0383-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.