Methylcobalamin Injection 5 mg/mL recall: Sterility Concern
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
Why was Methylcobalamin Injection 5 mg/mL recalled?
Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
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 #06132013@1, Exp 12/10/2013
- Product
- Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
- Recalling firm
- South Coast Specialty Compounding, Inc.
- Quantity
- 297 vials
- Distribution
- CA, IN
- Recall date
- September 18, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)