Methylcobalamin for injection recall: Sterility Concern
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Why was Methylcobalamin for injection recalled?
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
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 #: 02122018@77, 03092018@52,02122018@76,03142018@32, 01312018@40, 12282017@31, 01232018@17, 03052018@54, 03082018@39 02082018@55, 02082018@56, 03062018@69, 02052018@56,03122018@62 02072018@95, 03122018@63, 02072018@96, 03122018@64, 02072018@97; Exp 05/06/2018-09/10/2018
- Product
- Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
- Recalling firm
- Vitalab Pharmacy, Inc
- Quantity
- 178 vials
- Distribution
- The recalled product was distributed to patients throughout the United States.
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)