Bi-Mix Injectable Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Bi-Mix (20/1) Injectable 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. According to the rubric, FDA Class II recalls with potential impact on sterility and quality fall under the 'Severe' category (Score 4), as they represent a reasonable probability of temporary or medically reversible health consequences.
Plain-English summary
The Compounding Pharmacy of America is recalling Bi-Mix (20/1) Injectable, a sterile product intended to be kept frozen. 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 recall covers 12 ml vials of the product. The source text indicates that all lots distributed between November 2014 and May 2015 are affected, with specific lot codes including 03092015@34 and 9/5/2015. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Bi-Mix (20/1) Injectable, Sterile, Keep Frozen, 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 (3)
- All lots distributed between November 2014 and May 2015
- 03092015@34
- 9/5/2015
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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