Compounded Vitamin B12 and B6 Injection Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling MIC-B12+B6 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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of infection or serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling MIC-B12+B6 Injection, Multi-Dose Vial, Sterile, Room Temperature. The recall involves 473 ml total of the product, which was distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the source data, including lots expiring in May, June, July, and August 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, meaning there is a lack of assurance that the product is sterile. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions. The source text does not report any specific illnesses or injuries associated with the use of this product.
The recalled product
- Product
- MIC-B12+B6 Injection, 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 (11)
- All lots distributed between November 2014 and May 2015
- 02232015@93
- 5/24/2015
- 03132015@21
- 6/11/2015
- 04062015@38
- 7/5/2015
- 04082015@17
- 7/7/2015
- 04272015@83
- 7/26/2015
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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