Recalls / Class II
Class IID-0685-2017
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.
- Affected lot / code info
- 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.
Why it was recalled
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recalling firm
- Firm
- Isomeric Pharmacy Solution, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2401 S Foothill Dr Ste D, N/A, Salt Lake City, Utah 84109-1479
Distribution
- Quantity
- 851 vials
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-04-06
- FDA classified
- 2017-04-26
- Posted by FDA
- 2017-05-03
- Terminated
- 2017-08-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0685-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.