The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0166-2019·Announced 2018-11-07

Pharm D Solutions Recalls Lipo MIC-12 Compound Injectable Due to Sterility Concerns

Pharm D Solutions is recalling Lipo MIC-12 Compound Injectable vials 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectables) are classified as Severe (4).

Plain-English summary

Pharm D Solutions, LLC is recalling Lipo MIC-12 Compound Injectable, including 10 mL and 30 mL stock solution vials, distributed nationwide. The recall was initiated because of a lack of assurance of sterility for the product.

The affected product includes 896 vials and 64,000 milliliters of the compound injectable. Specific lot numbers and discard dates are listed in the official recall documentation. The product was manufactured in Houston, Texas.

Consumers and healthcare providers should stop using the affected lots and contact Pharm D Solutions or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable Compound
Hazard

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 (10)

  • Lot: a) 09042018:66/A Discard by: 3/3/2019
  • 07302018:65 Discard by: 1/26/2019
  • b) 08132018:75/A Discard by: 2/1/2019
  • 04172018:16 Discard by: 9/30/2018
  • 03212018:27 Discard by: 9/17/2018
  • 04242018:82 Discard by: 10/20/2018
  • 05142018:72 Discard by: 11/10/2018
  • 06192018:67 Discard by: 12/18/2018
  • 08142018:00 Discard by: 2/1/2019
  • 07302018:64 Discard by: 1/26/2019

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 →

Related recalls

Same manufacturer · Pharm D Solutions, LLC

See all →

Same hazard · sterility failure

See all →

Similar recalls