Biotin Injectable Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Biotin 10 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Biotin 10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate. The recall affects 66 mL total volume units distributed nationwide between November 2014 and May 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.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Biotin10 mg/ml Injectable, ml 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
- 05042015@46
- 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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