Methylcobalamin and Folic Acid Injectable Balanced recall: Sterility Concern
Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Why was Methylcobalamin and Folic Acid Injectable Balanced recalled?
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots
- Product
- Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Recalling firm
- Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Quantity
- 29 vials (9 mL and 30 mL)
- Distribution
- CO, GA, MI, and Puerto Rico
- Recall date
- May 1, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)