HCG Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling HCG 5,000 IU/ml injections due to FDA inspection findings of 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 injection with a lack of assurance of sterility, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
The Compounding Pharmacy of America is recalling HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate. The product is distributed nationwide. The recall involves all lots distributed between November 2014 and May 2015, specifically identified by the codes 03272015@23, 03312015@20, 04062015@4, and 05112015@23.
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 FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected HCG injections and contact their healthcare provider or the recalling firm for further instructions. The product is a sterile injection intended for refrigeration.
The recalled product
- Product
- HCG 5,000 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 (9)
- All lots distributed between November 2014 and May 2015
- 03272015@23
- 5/26/2015
- 03312015@20
- 5/30/2015
- 04062015@4
- 6/5/2015
- 05112015@23
- 7/10/2015
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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