The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0205-2019·Announced 2018-11-07

Pharm D Solutions Recalls Phentolamine, Papaverine, and Alprostadil Solution Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of a compounded medication solution because the company cannot guarantee 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a medication where sterility cannot be assured (implying a risk of infection) falls under the 'Severe' category, as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Pharm D Solutions, LLC is recalling specific lots of Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution. The recall was initiated because the company lacks assurance of the sterility of the affected product.

The affected product is identified by NDC 69699-1308-03 and is available in 343 milliliter containers. The recall covers specific lots with discard dates ranging from August 1, 2018, to January 28, 2019. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions. 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.

The recalled product

Product
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1308-03
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Compounded Medication
Hazard
Affected units
343

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 (6)

  • Lot: 04102018:07 Discard by: 10/7/2018
  • 05102018:18 Discard by: 11/6/2018
  • 05222018:64 Discard by: 8/1/2018
  • 07022018:46 Discard by: 12/29/2018
  • 08012018:81 Discard by: 1/28/2019
  • 06202018:97 Discard by: 9/17/2018

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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