Tri 2 (PAP/PHEN/ATROPINE) NR Injectable recall: Sterility Concern
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
Why was Tri 2 (PAP/PHEN/ATROPINE) NR Injectable recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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
- Recalling firm
- Wells Pharmacy Network LLC
- Quantity
- a) 238 vials and b) 607 vials
- Distribution
- Nationwide
- Recall date
- January 11, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)