The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0141-2019·Announced 2018-11-07

Pharm D Solutions Recalls Bi-Mix Injection Due to Sterility Concerns

Pharm D Solutions is recalling Bi-Mix Injection (Alprostadil/Lidocaine) because the company cannot ensure the product is sterile. The recall covers nationwide distribution.

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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Pharm D Solutions, LLC is recalling Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), NDC 69699-1323-05, due to a lack of assurance of sterility. The product is a 130-milliliter injection manufactured in Houston, Texas.

The recall is classified as FDA Class II. The affected lots are 04112018:34 (Discard by 10/7/2018), 08012018:66 (Discard by 1/28/2019), and 07262018:34 (Discard by 1/8/2019). The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact Pharm D Solutions or their healthcare provider for further instructions.

The recalled product

Product
Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
130

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: 04112018:34 Discard by: 10/7/2018
  • 08012018:66 Discard by: 1/28/2019
  • 07262018:34 Discard by: 1/8/2019

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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