Pharm D Solutions Recalls Glycerin Injectable Due to Sterility Concerns
Pharm D Solutions is recalling Glycerin 72% Injectable 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 agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of infection, aligning with the 'Severe' criteria for significant injury potential.
Plain-English summary
Pharm D Solutions, LLC is recalling Glycerin 72% (Lidocaine/Epi 2:1) Injectable, 180 milliliters, NDC 69699-1401-30. The recall is being conducted because of a lack of assurance of sterility. The affected lot is 07312018:13, with a discard by date of 9/28/2018.
The product was distributed nationwide. No specific illnesses or injuries are reported in the source text.
Healthcare providers and consumers should stop using the affected product and contact Pharm D Solutions for further instructions.
The recalled product
- Product
- Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1401-30
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Affected units
- 180
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: 07312018:13 Discard by: 9/28/2018
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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