Methylcobalamin 1mg/mL Injection w/Pres recall: Sterility Concern
Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
Why was Methylcobalamin 1mg/mL Injection w/Pres recalled?
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
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?
Lot #s: 139140@3, Exp 07/23/2018; 141106@1, Exp 08/21/2018; 142919@13, Exp 09/17/2018; 143291@6, Exp 09/23/2018; 145701@3, Exp 10/29/2018; 146932@3, Exp 11/19/2018
- Product
- Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
- Recalling firm
- La Vita Compounding Pharmacy, LLC
- Quantity
- 19,040 mL total dispensed in 10 mL and 30 mL vials
- Distribution
- Product was distributed to patients via patient specific prescription only in CA.
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)