The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0144-2019·Announced 2018-11-07

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

Pharm D Solutions is recalling 29 vials of Bi-Mix (Papaverine/Phentolamine) injectable and powder 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 FDA classified this recall as Class II, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug presents a significant risk of infection, aligning with the Severe category for high-risk medical products.

Plain-English summary

Pharm D Solutions, LLC is recalling 29 vials of Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) injectable and lyophilized powder. The recall is being conducted because of a lack of assurance of sterility. The affected product is distributed nationwide.

The recall includes specific lots of the injectable and powder forms, identified by lot numbers 04032018, 05242018, 06192018, and 06132018, with corresponding discard-by dates ranging from September 30, 2018, to December 16, 2018. The FDA has classified this recall as Class II.

Healthcare providers and patients should stop using the affected lots of Bi-Mix and contact Pharm D Solutions for further instructions or a replacement. Consumers should verify the lot numbers and discard-by dates on their product packaging against the information provided in this recall notice.

The recalled product

Product
Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
29

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 (4)

  • Lots: a)04032018:49 Discard by: 9/30/2018
  • 05242018:72 Discard by: 11/20/2018
  • b) 06192018:08 Discard by: 12/16/2018
  • 06132018:29 Discard by: 12/10/2018

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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