The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0170-2019·Announced 2018-11-07

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.

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, 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.

See all 79 products in this recall →

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