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Recall Observatory FDA recall evidence

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

April 06, 2017

Class II

Product summary

Firm
Isomeric Pharmacy Solution, LLC
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility