The Recall Desk
SevereFDA (Drugs)·D-1035-2013·Announced 2013-09-18

Wellness Pharmacy Recalls Dexpanthenol Vials Due to Sterility Concerns

Wellness Pharmacy is recalling 1,355 vials of Dexpanthenol 250 mg/mL due to laboratory results indicating microbial contamination and concerns about the reliability of testing.

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 microbial contamination of a sterile injectable product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Wellness Pharmacy, Inc. is recalling 1,355 single-use vials of Dexpanthenol 250 mg/mL PF, 1 mL. The product was distributed nationwide and in Puerto Rico. The specific lot number is 130605@52, with an expiration date of 12/2/13.

The recall was initiated due to laboratory results indicating microbial contamination. The FDA expressed concern that test results obtained from the recalling firm's contract testing laboratory may not be reliable, leading to a lack of assurance of sterility for the affected product lots.

Consumers and healthcare providers should stop using the affected vials and contact Wellness Pharmacy at 1-800-227-2627 for further instructions or a refund.

The recalled product

Product
Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627
Manufacturer
Wellness Pharmacy, Inc.
Category
Drug — Injectable Sterile Product
Hazard
Affected units
1,355

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)

  • Lot# 130605@52
  • Exp. 12/2/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Wellness Pharmacy, Inc. 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 6 products in this recall →

Related recalls

Same manufacturer · Wellness Pharmacy, Inc.

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Same hazard · microbial contamination

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