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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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