Pharm D Solutions Recalls Phenol Injectable Due to Sterility Concerns
Pharm D Solutions is recalling Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable due to a lack of assurance of sterility.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of infection or serious injury.
Plain-English summary
Pharm D Solutions, LLC is recalling Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable (NDC 69699-1432-10). The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is identified by Lot 08082018:86, with a discard by date of 2/4/2019. The quantity involved is 630 milliliters. The product was distributed nationwide.
The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions for further instructions.
The recalled product
- Product
- Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Affected units
- 630
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: 08082018:86 Discard by: 2/4/2019
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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