The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0441-2019·Announced 2019-02-20

Promise Pharmacy Recalls Trim Complete Injection Due to Sterility Concerns

Promise Pharmacy is recalling 158 vials of Trim Complete injection nationwide due to a lack of sterility assurance.

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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk contamination.

Plain-English summary

Promise Pharmacy, LLC is recalling 158 10 mL vials of Trim Complete injection. The product is a prescription-only compounded medication containing Methionine, Inositol, Choline, Thiamine, Riboflavin, Niacinamide, Dexpanthenol, Pyridoxine, Methylcobalamin, Leucine, and Chromium. The recall is being conducted due to a lack of sterility assurance.

The affected product is identified by Lot 10022018@6 with a Beyond Use Date of 12/31/2018. The recall covers distribution nationwide in the USA.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818…
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 (1)

  • Lot: 10022018@6 BUD: 12/31/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 51 recalled by Promise Pharmacy, 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 51 products in this recall →

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