The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0175-2019·Announced 2018-11-07

Pharm D Solutions Recalls Prostaglandin E1 Injectable Due to Sterility Concerns

Pharm D Solutions is recalling Prostaglandin E1 80 mcg/mL Injectable nationwide 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 serious health consequences.

Plain-English summary

Pharm D Solutions, LLC is recalling Prostaglandin E1 80 mcg/mL Injectable (NDC 69699-1337-05) because of a lack of assurance of sterility. The product is distributed nationwide and is available in 189-milliliter quantities.

The recall involves specific lots with discard dates ranging from September 24, 2018, to February 23, 2019. Affected lot numbers include 04252018:84, 03292018:62, 05312018:52, 07022018:82, 06122018:96, 07242018:22, and 08302018:71.

Healthcare providers and patients should stop using the affected product and contact Pharm D Solutions for further instructions or a replacement.

The recalled product

Product
Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1337-05
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
189

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 (7)

  • Lot: 04252018:84 Discard by: 10/22/2018
  • 03292018:62 Discard by: 9/24/2018
  • 05312018:52 Discard by: 11/27/2018
  • 07022018:82 Discard by: 11/17/2018
  • 06122018:96 Discard by: 12/9/2018
  • 07242018:22 Discard by: 1/20/2019
  • 08302018:71 Discard by: 2/23/2019

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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