Drug 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 Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
D-0685-2017
Product summary
- Event
- Event 76951
- Status
- Terminated
- Classification
- Class II
- Quantity
- 851 vials
- Official record key
drug-enforcement:D-0685-2017
Official wording
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Code information: 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.
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility