Why it was recalled
Lack of Assurance of Sterility
Product description
S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mountain Compounding RX.
Lot numbers, UPCs & expiration codes
Lot #: a) S03272019DT@04, Exp 09/27/2019, b) S01302019DT@08, Exp 08/30/2019, S02192019DH@10, Exp 08/19/2019, S03072019DH@01, Exp 09/07/2019, S03042019DH@02, Exp 09/07/2019, S03272019DT@04, Exp 09/27/2019, S04172019DT@03, Exp 10/17/2019, S04302019DT@11, Exp 10/30/2019, S05162019DH@20, Exp 11/16/2019, S05292019DT@03, Exp 11/29/2019, S06252019DH@17, Exp 12/25/2019, S07172019DT@12, Exp 01/17/2020, S07182019DT@08, Exp 01/18/2020,
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-0275-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 12, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- 108x 10 and 30 ml glass vials
- 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-0275-2020, 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 #: a) S03272019DT@04, Exp 09/27/2019, b) S01302019DT@08, Exp 08/30/2019, S02192019DH@10, Exp 08/19/2019, S03072019DH@01, Exp 09/07/2019, S03042019DH@02, Exp 09/07/2019, S03272019DT@04, Exp 09/27/2019, S04172019DT@03, Exp 10/17/2019, S04302019DT@11, Exp 10/30/2019, S05162019DH@20, Exp 11/16/2019, S05292019DT@03, Exp 11/29/2019, S06252019DH@17, Exp 12/25/2019, S07172019DT@12, Exp 01/17/2020, S07182019DT@08, Exp 01/18/2020,
- Postal code
- 85207-3761
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0275-2020
- Classification
- Class II
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Product quantity
- 108x 10 and 30 ml glass vials
- Termination date
- Apr 13, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. 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