The Recall Desk
SevereFDA (Drugs)·D-0359-2017·Announced 2017-01-11

Wells Pharmacy Recalls Injectable Glutamine/Arginine/Carnitine Vials Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 137 vials of compounded Glutamine/Arginine/Carnitine Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

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, which corresponds to a Severe severity score (4) under the rubric for significant injury/property-damage reports or high-risk scenarios.

Plain-English summary

Wells Pharmacy Network LLC is recalling 137 vials of Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial. 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. Known lot codes include 07012016@10, 08032016@42, and 08182016@11.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Hazard
Affected units
137

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 (4)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. Known lot code: 07012016@10
  • 08032016@42
  • 08182016@11.

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 →