L-Arginine Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling L-Arginine 100 mg/ml Injectable vials because FDA inspections found 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 sterility assurance is compromised, posing a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate. The product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, including lot 03242015@36 with an expiration date of 6/22/2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, resulting in a lack of assurance of sterility. The agency has classified this recall as Class II.
Healthcare providers and patients should stop using the affected L-Arginine injectable vials. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled product.
The recalled product
- Product
- L-Arginine 100 mg/ml Injectable, Multi-Dose 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 (3)
- All lots distributed between November 2014 and May 2015
- 03242015@36
- 6/22/2015
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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