Methylcobalamin Injection Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Methylcobalamin 25,000 mcg/ml injections due to FDA inspection findings of GMP violations that 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or structural defects (such as sterility failures in injectables) are classified as Severe.
Plain-English summary
The Compounding Pharmacy of America is recalling Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vials. 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 sterile, refrigerated, and distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically including lots with codes 02192015@39, 03172015@46, and 04162015@43. The total quantity involved is 99 ml.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Methylcobalamin 25,000 mcg/ml Intramuscular, 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 (7)
- All lots distributed between November 2014 and May 2015
- 02192015@39
- 5/20/2015
- 03172015@46
- 6/15/2015
- 04162015@43
- 7/15/2015
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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