The Recall Desk
SevereFDA (Drugs)·D-0353-2017·Announced 2017-01-11

Wells Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 15 vials of Dexamethasone Sodium Phosphate 200 mg/mL injectable compounded in Ocala, FL, due to a lack of 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 involves a lack of assurance of sterility in an injectable drug, which poses a risk of serious health consequences such as infection.

Plain-English summary

Wells Pharmacy Network LLC is voluntarily recalling 15 vials of Dexamethasone Sodium Phosphate 200 mg/mL, Injectable. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.

The recall includes all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. One known lot code is 07082016@25. The FDA has classified this recall as Class II.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pharmacy, Ocala, FL
Hazard
Affected units
15

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 (2)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. Known lot code: 07082016@25.

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 →