The Recall Desk
SevereFDA (Drugs)·D-0354-2017·Announced 2017-01-11

Wells Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Vials

Wells Pharmacy Network LLC is recalling 16 vials of Dexamethasone Sodium Phosphate 24 mg/mL injectable 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a sterility issue which is a significant safety concern, are rated as Severe (4).

Plain-English summary

Wells Pharmacy Network LLC is recalling 16 vials of Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial. The product was compounded by Wells Pharmacy in Ocala, FL. The recall is being conducted due to a lack of assurance of sterility.

The affected product includes all lot codes prepared between 02/22/2016 and 09/14/2016, within expiry. One known lot code is 08082016@45. The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on disposal or replacement.

The recalled product

Product
Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Hazard
Affected units
16

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: 08082016@45.

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 →