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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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
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.
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