Why it was recalled
Lack of Assurance of Sterility
Product description
S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX
Lot numbers, UPCs & expiration codes
Lot #:a) S07292019DH@01, Exp 9/29/19;S07232019DH@06, Exp 9/23/19;S06302019DH@05, Exp 8/30/19 b) S06112019DH@01, Exp 8/11/19; S06112019DH@11, Exp 8/11/19;S06142019DH@02, Exp 8/14/19; S06162019DH@01, 8/16/19,S06182019DH@34, Exp 8/18/19; S06242019DH@16, Exp 8/24/19; S06302019DH@05, Exp 8/30/19, S07102019DT@16, Exp 9/10/19; S07162019DH@02, Exp; 9/16/19, S07262019DH@03, Exp 9/26/19; S08022019DH@02, Exp 10/2/19; S07232019DH@06, Exp 9/23/19, c) S07102019DT@07, Exp 9/10/19;
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-0226-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 12, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- 81 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-0226-2020, 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) S07292019DH@01, Exp 9/29/19;S07232019DH@06, Exp 9/23/19;S06302019DH@05, Exp 8/30/19 b) S06112019DH@01, Exp 8/11/19; S06112019DH@11, Exp 8/11/19;S06142019DH@02, Exp 8/14/19; S06162019DH@01, 8/16/19,S06182019DH@34, Exp 8/18/19; S06242019DH@16, Exp 8/24/19; S06302019DH@05, Exp 8/30/19, S07102019DT@16, Exp 9/10/19; S07162019DH@02, Exp; 9/16/19, S07262019DH@03, Exp 9/26/19; S08022019DH@02, Exp 10/2/19; S07232019DH@06, Exp 9/23/19, c) S07102019DT@07, Exp 9/10/19;
- Postal code
- 85207-3761
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0226-2020
- Classification
- Class II
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Product quantity
- 81 vials
- Termination date
- Apr 13, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML 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