Why it was recalled
Lack of Assurance of Sterility
Product description
S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.
Lot numbers, UPCs & expiration codes
Lot #: S02072019DT@08, EXP 9/7/19; S02132019DH@06, Exp 8/13/19; S02232019DH@06 Exp 8/23/19; S02282019DH@07 Exp 8/28/19; S02252019DH@01 Exp 8/25/19; S02122019DH@06 Exp 8/12/19; S03132019DT@02 Exp 9/13/19;03202019DT@01 Exp 9/20/19; S03282019DT@05 Exp 9/28/19 S03212019DT@01 Exp 9/21/19 S04202019DT@03 Exp 10/20/19 S0412019DT@03 Exp 10/10/19 S04102019DT@12 Exp 10/10/19 S04232019DT@02 Exp 10/23/19 S03132019DT@03 Exp 9/13/19 S04232019DT@05 Exp 10/23/19 S05072019DT@07 Exp 11/7/19 S05242019DT@04 Exp 11/24/19 S06032019DT@06 Exp 12/3/19 S06182019DH@23 Exp 12/18/19 S06182019DH@22 Exp 12/18/19; S06252019DH@15, Exp 12/25/19 S06182019DH@24 Exp 12/18/19 S06262019DH@15 Exp 12/26/19 S07032019DT@03 Exp 1/3/20 S07132019DH@02 Exp 1/13/20 S07232019DH@11 Exp /23/20 S07182019DT@09 Exp 1/18/20 S07292019DH@02 Exp 1/29/20 S07312019DH@10 Exp 1/31/20 S05072019DT@07 Exp, 9/30/19 S06182019DH@23 Exp,11/30/19
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-0285-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 12, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- 559 x 5, 10, 13 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-0285-2020, 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 #: S02072019DT@08, EXP 9/7/19; S02132019DH@06, Exp 8/13/19; S02232019DH@06 Exp 8/23/19; S02282019DH@07 Exp 8/28/19; S02252019DH@01 Exp 8/25/19; S02122019DH@06 Exp 8/12/19; S03132019DT@02 Exp 9/13/19;03202019DT@01 Exp 9/20/19; S03282019DT@05 Exp 9/28/19 S03212019DT@01 Exp 9/21/19 S04202019DT@03 Exp 10/20/19 S0412019DT@03 Exp 10/10/19 S04102019DT@12 Exp 10/10/19 S04232019DT@02 Exp 10/23/19 S03132019DT@03 Exp 9/13/19 S04232019DT@05 Exp 10/23/19 S05072019DT@07 Exp 11/7/19 S05242019DT@04 Exp 11/24/19 S06032019DT@06 Exp 12/3/19 S06182019DH@23 Exp 12/18/19 S06182019DH@22 Exp 12/18/19; S06252019DH@15, Exp 12/25/19 S06182019DH@24 Exp 12/18/19 S06262019DH@15 Exp 12/26/19 S07032019DT@03 Exp 1/3/20 S07132019DH@02 Exp 1/13/20 S07232019DH@11 Exp /23/20 S07182019DT@09 Exp 1/18/20 S07292019DH@02 Exp 1/29/20 S07312019DH@10 Exp 1/31/20 S05072019DT@07 Exp, 9/30/19 S06182019DH@23 Exp,11/30/19
- Postal code
- 85207-3761
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0285-2020
- Classification
- Class II
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Product quantity
- 559 x 5, 10, 13 ml glass vials
- Termination date
- Apr 13, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, 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