Compounded HCG and Methylcobalamin Injection Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin 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 the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Sterile, Refrigerate. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product is a 61 ml multi-dose vial. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the structured product information.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- HCG 2,500 IU/ml + Methylcobalamin 500 mcg/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 (15)
- All lots distributed between November 2014 and May 2015
- 03242015@5
- 5/23/2015
- 05042015@78
- 7/3/2015
- 03262015@2
- 5/25/2015
- 04062015@52
- 6/5/2015
- 04242015@58
- 6/23/2015
- 05072015@17
- 7/6/2015
- 05082015@19
- 7/7/2015
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.
See all 382 products in this recall →Related recalls
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