B-Complex Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling B-Complex 100 mg/ml Injection 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe; while specific injury reports are not listed, the lack of sterility assurance in an injectable drug is a significant hazard that aligns with the Severe classification for Class II drug recalls involving quality/sterility failures.
Plain-English summary
The Compounding Pharmacy of America is recalling B-Complex 100 mg/ml Injection, Sterile, Refrigerate. The product is distributed nationwide in 33 mL quantities. The recall covers all lots distributed between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, resulting in a lack of assurance of sterility.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- B-Complex 100 mg/ml 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 (2)
- All lots distributed between November 2014 and May 2015
- 02202015@47 5/21/2015
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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