Mitomycin Injection Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Mitomycin Injection 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance issues in injectable products.
Plain-English summary
The Compounding Pharmacy of America is recalling Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product consists of single-dose syringes containing Mitomycin and Sodium Chloride. The total volume of the recalled product is 2,255 ml. The product was distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.
Healthcare providers and patients should stop using the recalled product and contact the recalling firm for instructions on return or disposal. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Refrigerate, 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 (17)
- All lots distributed between November 2014 and May 2015
- 10222014@55
- 10/22/2015
- 10032014@43
- 10/3/2015
- 12012014@42
- 12/1/2015
- 01092015@35
- 1/9/2016
- 02022015@52
- 2/2/2016
- 02232015@78
- 2/23/2016
- 03122015@81
- 3/11/2016
- 03312015@38
- 3/30/2016
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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