The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0137-2019·Announced 2018-11-07

Pharm D Solutions Recalls Arginine Injections Due to Sterility Concerns

Pharm D Solutions is recalling Arginine Injections 100 mcg/mL due to a lack of assurance of sterility. The affected lots were 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Pharm D Solutions, LLC is voluntarily recalling Arginine Injections 100 mcg/mL (NDC 69699-1414-20) due to a lack of assurance of sterility. The recall involves 7,150 milliliters of the product distributed nationwide.

The specific lots affected are 04112018:83 (discard by 10/8/2018), 03202018:48 (discard by 9/16/2018), and 04302018:91 (discard by 10/27/2018). The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should discontinue use of the affected lots and contact Pharm D Solutions, LLC for further instructions or returns. Consumers should verify the lot number and discard date on their product packaging to determine if they are affected.

The recalled product

Product
Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
7,150

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 (3)

  • Lots: 04112018:83 Discard by: 10/8/2018
  • 03202018:48 Discard by: 9/16/2018
  • 04302018:91 Discard by: 10/27/2018

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.

See all 79 products in this recall →

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