SCA Pharmaceuticals Recalls Calcium Gluconate Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 76 bags of Calcium Gluconate 2 g in 0.9% Sodium Chloride due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury risks or hospitalization reports.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling 76 bags of Calcium Gluconate 2 g added to 0.9% Sodium Chloride 50 mL Bag. The product is identified by NDC 70004-0510-30, Lot 20170920@20, and a Beyond Use Date of 11/09/2017.
The recall was initiated because of a lack of assurance of sterility. The product was distributed nationwide in the United States.
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals for further instructions.
The recalled product
- Product
- Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 76
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 20170920@20 BUD: 11/09/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by SCA Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · SCA Pharmaceuticals, LLC
See all →- HighPhenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
- HighInjectable midazolam HCl recalled due to sterility assurance failure
FDA (Drugs) · 2024-04-03
- HighFentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
FDA (Drugs) · 2024-04-03
- HighHydromorphone Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighHYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29