Cyanocobalamin Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Cyanocobalamin 1,000 mcg/ml multi-dose vials because an FDA inspection identified 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 source text explicitly states the agency classification is Class II. According to the rubric, if the agency's own classification is FDA Class II, the score must be at least 4 (Severe).
Plain-English summary
The Compounding Pharmacy of America is recalling Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature. The recall covers 6,615 mL of 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 agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected vials and contact the recalling firm for further instructions. The specific lot numbers and expiration dates are listed in the structured product information.
The recalled product
- Product
- Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, 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 (17)
- All lots distributed between November 2014 and May 2015 05062015@2
- 8/4/2015
- 03182015@9
- 6/16/2015
- 03242015@9
- 6/22/2015
- 03312015@72
- 6/29/2015
- 04152015@12
- 7/14/2015
- 04152015@13
- 05052015@93
- 8/3/2015
- 05012015@35
- 7/30/2015
- 05072015@10
- 8/5/2015
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.
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