Recalls / Class II
Class IID-1328-2019
Product
Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
- Affected lot / code info
- Lot #: 02202019:53/A Exp. 08/18/2019; 04012019:67/A, 04022019:47/A Exp. 09/28/2019; 04042019:04/A Exp. 09/30/2019; 04082019:38/A Exp. 10/02/2019; 04302019:49/A Exp. 10/27/2019; 05062019:09 Exp. 11/02/2019
Why it was recalled
Lack of Sterility Assurance.
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Press Release
- Type
- FDA Mandated
- Address
- 1304 S Loop W, N/A, Houston, Texas 77054-4010
Distribution
- Quantity
- 669 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-05-23
- FDA classified
- 2019-06-07
- Posted by FDA
- 2019-06-19
- Terminated
- 2021-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1328-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.