Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol recall: Sterility Concern
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy…
Why was Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol recalled?
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products 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: 09003, Exp 04/17/17; 11003, Exp 06/21/17; 11035, Exp 07/03/17; 11039, Exp 07/05/17; 12002, Exp 07/23/17; 12012, Exp 07/30/17.
- Product
- Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy…
- Recalling firm
- Isomeric Pharmacy Solution, LLC
- Quantity
- 851 vials
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- May 3, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)