Why it was recalled
Lack of Assurance of Sterility
Product description
S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
Lot numbers, UPCs & expiration codes
Lot #: a) S04232019DT@07, Exp 8/23/19; S07302019DH@09, Exp 11/30/19, b) S05142019DT@14, Exp 9/14/19; S06182019DH@30, Exp 10/18/19; S06182019DH@13, Exp 10/18/19;
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-0217-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 12, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- 3x50ml, 6x100ml 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-0217-2020, 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) S04232019DT@07, Exp 8/23/19; S07302019DH@09, Exp 11/30/19, b) S05142019DT@14, Exp 9/14/19; S06182019DH@30, Exp 10/18/19; S06182019DH@13, Exp 10/18/19;
- Postal code
- 85207-3761
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0217-2020
- Classification
- Class II
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Product quantity
- 3x50ml, 6x100ml glass vials
- Termination date
- Apr 13, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, 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