HCG Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling HCG 1,500 IU/ml Injection vials because an FDA inspection 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant harm (such as sterility issues in injectable drugs) are classified as Severe.
Plain-English summary
The Compounding Pharmacy of America is recalling HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate. The recall involves 40 ml total vials distributed nationwide between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The specific hazard is a lack of assurance of sterility.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on return or replacement.
The recalled product
- Product
- HCG 1,500 IU/ml Injection, 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 (7)
- All lots distributed between November 2014 and May 2015
- 04012015@78
- 5/31/2015
- 04222015@61
- 6/21/2015
- 04302015@55
- 6/29/2015
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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