Dexpanthenol Injection Recalled for Lack of Sterility Assurance
Pharm D Solutions is recalling Dexpanthenol Injection due to a lack of assurance of sterility. The product was distributed nationwide.
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 a lack of sterility assurance, which poses a risk of serious health consequences such as infection, meeting the criteria for a Severe rating.
Plain-English summary
Pharm D Solutions, LLC is recalling Dexpanthenol Injection, 250 mg/mL (NDC 69699-1610-30). The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product consists of 2000 milliliter containers with Lot 08292018:08 and a discard by date of 2/23/2019. The recall is classified as Class II by the U.S. Food and Drug Administration.
The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact Pharm D Solutions, LLC for further instructions.
The recalled product
- Product
- Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 69699-1610-30
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 2,000
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 (1)
- Lot: 08292018:08 Discard by: 2/23/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 79 recalled by Pharm D Solutions, 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.
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