Why it was recalled
Lack of Assurance of Sterility
Product description
S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, Red Mountain Compounding Rx
Lot numbers, UPCs & expiration codes
Lot #:a) S04242019DT@15, Exp 10/24/19; S05012019DH@03, Exp 11/1/19; S05072019DT@10, Exp 11/7/19; S05072019DT@12, Exp 11/7/19; S06202019DT@03, Exp 12/20/19; S06202019DT@04, Exp 12/20/19; S07222019DH@05, Exp 07/22/2019 b) S06272019DT@06, Exp 12/27/19;
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-0214-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 12, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- 10x50m ml and 1x10 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-0214-2020, 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) S04242019DT@15, Exp 10/24/19; S05012019DH@03, Exp 11/1/19; S05072019DT@10, Exp 11/7/19; S05072019DT@12, Exp 11/7/19; S06202019DT@03, Exp 12/20/19; S06202019DT@04, Exp 12/20/19; S07222019DH@05, Exp 07/22/2019 b) S06272019DT@06, Exp 12/27/19;
- Postal code
- 85207-3761
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0214-2020
- Classification
- Class II
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Product quantity
- 10x50m ml and 1x10 ml glass vials
- Termination date
- Apr 13, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx Only, 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