The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0142-2019·Announced 2018-11-07

Bi-Mix Injection Recalled for Lack of Sterility Assurance

Pharm D Solutions is recalling Bi-Mix Injection due to a lack of assurance of sterility. The product is distributed nationwide.

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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an injectable drug warrants a score of 4 (Severe).

Plain-English summary

Pharm D Solutions, LLC is recalling Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL), NDC 69699-1305-03. The recall is being conducted because of a lack of assurance of sterility. The affected product quantity is 148 milliliters.

The recall covers lots 04112018:37 (Discard by: 10/1/2018), 06202018:70 (Discard by: 12/16/2018), and 08082018:95 (Discard by: 2/4/2019). The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a return.

The recalled product

Product
Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
148

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: 04112018:37 Discard by: 10/1/2018
  • 06202018:70 Discard by: 12/16/2018
  • 08082018:95 Discard by: 2/4/2019

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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