Tri-Mix ST9A Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix ST9A Injectable due to FDA inspection findings of GMP violations that may 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. According to the rubric, 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 potential impact on sterility of an injectable drug is a significant health risk warranting a high severity rating.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and dates include 02112015@19, 8/10/2015; 02032015@77, 8/2/2015; 04012015@19, 9/28/2015; and 04272015@54, 10/24/2015.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- Tri-Mix ST9A (30 mg/2 mg/80 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 (9)
- All lots distributed between November 2014 and May 2015
- 02112015@19
- 8/10/2015
- 02032015@77
- 8/2/2015
- 04012015@19
- 9/28/2015
- 04272015@54
- 10/24/2015
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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