Pharm D Solutions Recalls Phenol Injection Due to Sterility Concerns
Pharm D Solutions is recalling Phenol 5% and Glycerin Aqueous Solution 10 mL Injection due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks.
Plain-English summary
Pharm D Solutions, LLC is recalling Phenol 5% and Glycerin Aqueous Solution 10 mL Injection (NDC 69699-1431-10). The recall was initiated because of a lack of assurance of sterility for the product.
The affected product is distributed nationwide. The recall covers a total quantity of 1,139 milliliters. Specific lots affected include Lot 05082018:59 with a discard by date of 11/4/2018, and Lot 08082018:57 with a discard by date of 2/4/2019.
Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a return.
The recalled product
- Product
- Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1431-10
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 1,139
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: 05082018:59 Discard by: 11/4/2018
- 08082018:57 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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