The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0174-2019·Announced 2018-11-07

Pharm D Solutions Recalls Prostaglandin E1 Injectable Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of Prostaglandin E1 40 mcg/mL Injectable because the agency cannot assure the product is sterile.

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 source text identifies this as an FDA Class II recall involving a lack of assurance of sterility in an injectable drug, which aligns with the rubric criteria for Severe severity due to the potential for significant injury from non-sterile medical products.

Plain-English summary

Pharm D Solutions, LLC is recalling specific lots of Prostaglandin E1 40 mcg/mL Injectable. The recall was initiated because the company cannot assure the sterility of the affected product.

The affected product is identified by NDC 69699-1347-05 and is distributed nationwide. The recall covers four specific lots with the following discard-by dates: Lot 04262018:95 (discard by 10/22/2018), Lot 03292018:59 (discard by 9/24/2018), Lot 05312018:66 (discard by 11/27/2018), and Lot 06122018:07 (discard by 12/9/2018).

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1347-05
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
154

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 (4)

  • Lot: 04262018:95 Discard by: 10/22/2018
  • 03292018:59 Discard by: 9/24/2018
  • 05312018:66 Discard by: 11/27/2018
  • 06122018:07 Discard by: 12/9/2018

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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