B-Complex Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling B-Complex Injection nationwide because FDA inspections found GMP violations that may affect 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 B-Complex Injection, Sterile, Refrigerate, distributed nationwide. The recall involves 1,397 mL of total volume across multiple lots distributed 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 for further instructions.
The recalled product
- Product
- B-Complex Injection, 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 (20)
- All lots distributed between November 2014 and May 2015
- 02192015@21
- 5/20/2015
- 03032015@3
- 6/1/2015
- 02242015@37
- 5/25/2015
- 03122015@27
- 6/10/2015
- 03182015@48
- 6/16/2015
- 03272015@14
- 6/25/2015
- 04072015@16
- 7/6/2015
- 04072015@18
- 04202015@80
- 7/19/2015
- 04222015@85
- 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.
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