HCG Injection Recalled Due to Lack of Assurance of Sterility
The Compounding Pharmacy of America is recalling HCG 1,100 IU/ml Injection 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 the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate. The recall is due to a lack of assurance of sterility, as FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.
The affected product was distributed nationwide. The recall covers 1,558 ml total across multiple lots distributed between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- HCG 1,100 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 (20)
- All lots distributed between November 2014 and May 2015
- 05062015@32
- 8/4/2015
- 02272015@16
- 5/28/2015
- 03032015@33
- 6/1/2015
- 03042015@36
- 6/2/2015
- 03062015@43
- 6/4/2015
- 03092015@77
- 6/7/2015
- 03092015@92
- 03132015@17
- 11/2015
- 03162015@23
- 14/2015
- 03172015@40
- 5/2015
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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