Agency classClass IIOur severity:Severe FDA (Drugs)·D-0407-2017·Announced 2017-01-11

FDA Recalls Tri 1 Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling Tri 1 (PAP/PHEN/ATROPINE) NR Injectable vials because the product lacks assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Wells Pharmacy Network LLC is recalling specific vials of Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL. The recall includes 2 mL and 5 mL vials compounded by Wells Pharmacy in Ocala, Florida. The total quantity recalled is 257 vials of the 2 mL size and 460 vials of the 5 mL size.

The recall is being conducted because the product lacks assurance of sterility. This affects all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration dates. The distribution pattern for these products was nationwide.

Healthcare providers and patients should stop using the affected vials. The source text does not provide specific instructions for disposal or return, but users should contact their healthcare provider or the recalling firm for guidance.

The recalled product

Product: Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 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: sterility
infection

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: 04072016@10
05102016@18
06232016@12
08182016@26 b) Known lot code: 04122016@19
05042016@18
06142016@43
07122016@40
07262016@47.

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.

See all 97 products in this recall →

Same manufacturer · Wells Pharmacy Network LLC

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Same hazard · sterility