FDA Recalls Tri 2 Injectable Due to Lack of Sterility Assurance
Wells Pharmacy Network LLC is recalling Tri 2 (PAP/PHEN/ATROPINE) NR Injectable vials because the product lacks assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for serious adverse health consequences (such as lack of sterility in injectables) are rated as Severe.
Plain-English summary
Wells Pharmacy Network LLC is recalling Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, in 2 mL and 5 mL vials. The recall is due to a lack of assurance of sterility. The affected product was compounded by Wells Pharmacy in Ocala, FL, and distributed nationwide.
The recall includes 238 vials of the 2 mL size and 607 vials of the 5 mL size. All lot codes for product prepared between 02/22/2016 and 09/14/2016, within expiry, are affected. Specific known lot codes include 05042016@19, 06142016@28, 07262016@34, and 09072016@22 for the 2 mL vials, and 04112016@8, 05232016@2, 06212016@21, 07012016@22, and 09082016@31 for the 5 mL vials.
Healthcare providers and patients should stop using the recalled product and contact Wells Pharmacy Network LLC for further instructions or a replacement.
The recalled product
- Product
- Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. a) Known lot code: 05042016@19
- 06142016@28
- 07262016@34
- 09072016@22 b) Known lot code: 04112016@8
- 05232016@2
- 06212016@21
- 07012016@22
- 09082016@31.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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