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 assurance.
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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility assurance issues for injectable products.
Plain-English summary
The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml + Methylcobalamin 1 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate. The product is a 48 ml total volume sterile injection manufactured in Knoxville, Tennessee.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency classification for this recall is Class II. The source text does not report any specific illnesses or injuries associated with the product.
The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 03312015@25, 03312015@45, 03312015@50, and 04292015@58. The distribution pattern is listed as nationwide. 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 1,000 IU/ml + Methylcobalamin 1 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- 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
- 03312015@25
- 5/30/2015
- 03312015@45
- 03312015@50
- 04292015@58
- 6/28/2015
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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