S-calcium Gluconate 10% Injection recall: Sterility Concern
S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX
Why was S-calcium Gluconate 10% Injection recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) 03072019DH@08, Exp 9/7/19; S04042019DT@04, Exp 10/4/19; S05012019DH@04, Exp 11/1/19; S05242019DT@12, Exp 11/24/19; S06182019DH@12 Exp 12/18/19; S06182019DH@32, Exp 12/18/19; S07152019DH@02, Exp 1/15/20; b) S06202019DT@05, Exp 12/20/19;
- Product
- S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Quantity
- 18x10 ml and 1x5 ml glass vials
- Distribution
- Nationwide in the USA
- Recall date
- November 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)