FDAClass IINovember 7, 2018

Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable recall: Sterility Concern

Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas

Why was Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: a) 04132018:97 Discard by: 10/10/2018; 04032018:25 Discard by: 9/30/2018; b) 04162018:29 Discard by: 10/11/2018; 03282018:80 Discard by: 9/24/2018; 06122018:06 Discard by: 12/9/2018; 08132018:55 Discard by: 2/9/2019

Product
Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas
Recalling firm
Pharm D Solutions, LLC
Quantity
553 vials
Distribution
Nationwide
Recall date
November 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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