HCG and Methylcobalamin Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings regarding sterility and quality.
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 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 5,000 IU/ml + Methylcobalamin 500 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate. The product is a 12 ml total volume injection distributed nationwide.
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.
All lots distributed between November 2014 and May 2015 are affected. Consumers and healthcare providers should stop using the product and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- HCG 5,000 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
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
- 04032015@53
- 6/2/2015
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.
See all 382 products in this recall →Related recalls
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