Why it was recalled
Lack of Assurance of Sterility
Product description
S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s07092019dt@19, Exp 8/9/19; S07292019DH@09, Exp 8/29/19; S02192019DH@10, Exp 8/19/19; S03302019DT@02, Exp 9/30/19; S05062019DH@12, Exp 11/6/19; S06162019DH@13, Exp 12/16/19; S07102019DT@16, Exp 1/10/20; S07132019DT@05, Exp 1/13/20; S01302019DT@08, Exp 8/30/19; S03072019DH@01, Exp 9/7/19; S02192019DH@12, Exp 8/19/19; S03072019DH@02, Exp 9/7/19; S03272019DT@04, Exp 9/27/19; S04172019DT@03, Exp 10/17/19; S04302019DT@11, Exp 10/30/19; S05162019DH@20, Exp 11/16/19; S05292019DT@03, Exp 11/29/19; S06252019DH@17, Exp 12/25/19; S07172019DT@12, Exp 1/17/20; S07182019DT@08, Exp 1/18/20; S05242019DT@10, Exp 11/24/19 Red Mountain Compounding RX
Lot numbers, UPCs & expiration codes
Lot #: S07022019DT@09, Exp 10/2/19; S05082019DT@08, Exp 8/8/19; S06042019DT@07, Exp 9/4/19
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0274-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 12, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-0274-2020, exactly as published.
Show all FDA fields
- City
- Mesa
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 83669
- Address
- 6828 E Brown Rd Ste 101
- Code information
- Lot #: S07022019DT@09, Exp 10/2/19; S05082019DT@08, Exp 8/8/19; S06042019DT@07, Exp 9/4/19
- Postal code
- 85207-3761
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0274-2020
- Classification
- Class II
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Termination date
- Apr 13, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s07092019dt@19, Exp 8/9/19; S07292019DH@09, Exp 8/29/19; S02192019DH@10, Exp 8/19/19; S03302019DT@02, Exp 9/30/19; S05062019DH@12, Exp 11/6/19; S06162019DH@13, Exp 12/16/19; S07102019DT@16, Exp 1/10/20; S07132019DT@05, Exp 1/13/20; S01302019DT@08, Exp 8/30/19; S03072019DH@01, Exp 9/7/19; S02192019DH@12, Exp 8/19/19; S03072019DH@02, Exp 9/7/19; S03272019DT@04, Exp 9/27/19; S04172019DT@03, Exp 10/17/19; S04302019DT@11, Exp 10/30/19; S05162019DH@20, Exp 11/16/19; S05292019DT@03, Exp 11/29/19; S06252019DH@17, Exp 12/25/19; S07172019DT@12, Exp 1/17/20; S07182019DT@08, Exp 1/18/20; S05242019DT@10, Exp 11/24/19 Red Mountain Compounding RX
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2019