The Recall Desk
SevereFDA (Drugs)·D-1033-2013·Announced 2013-09-18

Wellness Pharmacy Recalls Phenylbutyrate Due to Sterility Concerns

Wellness Pharmacy is recalling Phenylbutyrate 200 mg/mL vials because laboratory results indicate microbial contamination and the FDA has concerns about the reliability of the testing data.

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 drug product, which aligns with the rubric criteria for Severe severity involving significant health risks.

Plain-English summary

Wellness Pharmacy, Inc. is recalling 200 vials of Phenylbutyrate 200 mg/mL in 10 mL, 25 mL, and 50 mL sizes. The affected lot number is 130621@28, with a use-by date of 10/19/2013. The product was distributed nationwide and in Puerto Rico.

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 regarding the sterility of the product.

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

The recalled product

Product
NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627
Manufacturer
Wellness Pharmacy, Inc.
Category
Drug — Sterile Injectable
Hazard
Affected units
200

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# 130621@28
  • Use by: 10/19/2013

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 →

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Same manufacturer · Wellness Pharmacy, Inc.

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Same hazard · microbial contamination

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