Methylcobalamin Injectable Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Methylcobalamin 10,000 mcg/ml Injectable due to 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug represents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for serious harm.
Plain-English summary
The Compounding Pharmacy of America is recalling Methylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate. The recall involves 255 ml total of the product distributed nationwide between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The specific hazard is a lack of assurance of sterility.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on how to proceed.
The recalled product
- Product
- Methylcobalamin 10,000 mcg/ml Injectable, 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 (7)
- All lots distributed between November 2014 and May 2015
- 03052015@5
- 6/3/2015
- 03162015@63
- 6/14/2015
- 04222015@70
- 7/21/2015
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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