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.
Reported: May 3, 2017 Initiated: April 6, 2017 #D-0685-2017
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Details
- Recalling Firm
- Isomeric Pharmacy Solution, LLC
- Units Affected
- 851 vials
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Isomeric Pharmacy Solution, LLC. Units affected: 851 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 3, 2017. Severity: Moderate. Recall number: D-0685-2017.
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