Agency classClass IIOur severity:Severe FDA (Drugs)·D-0330-2017·Announced 2017-01-11

Wells Pharmacy Recalls QUAD3 Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling QUAD3 injectable vials because the FDA determined there is a lack of 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Wells Pharmacy Network LLC is recalling QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, 2 mL and 5 mL vials, compounded in Ocala, Florida. The recall was initiated due to a lack of assurance of sterility in the product.

The affected units include 1,312 vials of the 2 mL size and 3,354 vials of the 5 mL size. The recall covers all lot codes of product prepared between February 22, 2016, and September 14, 2016, that are within their expiry dates. Specific lot codes are listed in the recall documentation.

The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

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
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Injectable
Hazard: lack-of-sterility

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 (20)

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

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 · lack of sterility