Cyanocobalamin and B-Complex Injection Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Cyanocobalamin and B-Complex injections due to FDA inspection findings of 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, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml multi-dose vials. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a sterile, room-temperature multi-dose vial with a total volume of 33 mL. The recall covers all lots distributed nationwide between November 2014 and May 2015.
Consumers and healthcare providers should stop using the recalled product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, 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 (3)
- All lots distributed between November 2014 and May 2015
- 05052015@24
- 8/3/2015
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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