Compounded Methylcobalamin Injection Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling MIC+Methylcobalamin 4000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issues) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
The Compounding Pharmacy of America is recalling MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature. The recall involves 1,076 ml of the product distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the structured product information.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Patients who have received this injection should contact their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with the product.
The recalled product
- Product
- MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded 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 (17)
- All lots distributed between November 2014 and May 2015
- 03172015@50
- 6/15/2015
- 04142015@11
- 7/13/2015
- 03232015@32
- 6/21/2015
- 03232015@37
- 03302015@53
- 6/28/2015
- 04142015@10
- 04302015@47
- 7/29/2015
- 04292015@84
- 7/28/2015
- 05042015@55
- 8/2/2015
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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