Agency classClass IIOur severity:Severe FDA (Drugs)·D-0384-2017·Announced 2017-01-11

Wells Pharmacy Recalls QUAD2 Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling QUAD2 injectable vials because they may not be sterile. The recall covers vials prepared between February and September 2016.

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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious consequences.

Plain-English summary

Wells Pharmacy Network LLC is recalling QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable vials. The recall includes 2 mL and 5 mL vials compounded by Wells Pharmacy in Ocala, Florida. The total quantity recalled is 191 2 mL vials and 794 5 mL vials.

The recall was initiated due to a lack of assurance of sterility. The affected products were prepared between February 22, 2016, and September 14, 2016, and are within their expiration dates. Specific lot codes for the 2 mL vials include 04222016@8, 06142016@42, and 08152016@17. Specific lot codes for the 5 mL vials include 03312016@8, 05182016@15, and 08092016@18.

The product was distributed nationwide. Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description.

The recalled product

Product: QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, 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 (6)

All lot codes of product prepared between 02/22/2016 and 09/14/2016
within expiry. a) Known lot code: 04222016@8
06142016@42
08152016@17 b) Known lot code: 03312016@8
05182016@15
08092016@18

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