Copper Sulfate Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Copper Sulfate 2 mg/ml Injectable due to 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 and involves a sterile injectable product where GMP violations impact sterility assurance, posing a risk of serious injury or death from infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Copper (Cupric) Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate. The product is a 35 mL sterile injectable solution. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.
The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 05042015@47 and 8/2/2015. The product was distributed nationwide. The agency has classified this recall as Class II.
Healthcare providers and patients should discontinue use of the recalled product. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, 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 (3)
- All lots distributed between November 2014 and May 2015
- 05042015@47
- 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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