Cholecalciferol Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Cholecalciferol 50,000 IU/ml Injectable vials because FDA inspections identified 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly given the risk of sterility failure in an injectable product.
Plain-English summary
The Compounding Pharmacy of America is recalling Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate. The product is distributed nationwide and consists of 102 mL total volume vials. The recall covers all lots distributed between November 2014 and May 2015, including specific lot codes 03202015@26, 04282015@1, and 05042015@53.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected product. Consumers should contact their healthcare provider or the recalling firm for further instructions on how to handle or return the medication.
The recalled product
- Product
- Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
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 (7)
- All lots distributed between November 2014 and May 2015
- 03202015@26
- 6/18/2015
- 04282015@1
- 7/27/2015
- 05042015@53
- 8/2/2015
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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