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.
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 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.
- 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
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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