FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix MEDIUM Injectable nationwide due to FDA inspection findings of GMP violations that impact sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls involving significant quality issues like sterility assurance are categorized as Severe (Score 4).
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable. The recall covers 802 ml of the product distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations create a lack of assurance regarding the sterility of the product, potentially impacting its quality.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
- 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 (13)
- All lots distributed between November 2014 and May 2015
- 12182014@66
- 6/16/2015
- 01052015@51
- 7/4/2015
- 01192015@33
- 7/18/2015
- 02192015@9
- 8/18/2015
- 05042015@38
- 10/31/2015
- 04012015@63
- 9/28/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America 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.
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