The Apothecary Recalls Calcium Gluconate IV Bags Due to Sterility Risk
The Apothecary recalls unexpired lots of Calcium Gluconate 1% IV bags due to lack of sterility assurance. Check lot numbers and consult your provider.
Stop using this now
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Contact the company
What happened, in plain English
W & C dba The Apothecary is recalling all unexpired lots of Calcium Gluconate 1% -- 1000 mL VIAFLEX IV bags because the validation for beyond-use dating was not substantiated. This means there is no assurance that the medication remains sterile during its labeled usage period. The recall affects approximately 40,000 mL of product distributed in Minnesota. Read more at govinfonow.com/recall/42579-the-apothecary-recalls-calcium-gluconate-iv-bags-due-to-sterility.
Source Summary by GovInfoNow · govinfonow.com/recall/42579-the-apothecary-recalls-calcium-gluconate-iv-bags-due-to-sterility · Updated October 9, 2026 · FDA enforcement record: FDA #D-1508-2016
Cite this page
“The Apothecary Recalls Calcium Gluconate IV Bags Due to Sterility Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42579-the-apothecary-recalls-calcium-gluconate-iv-bags-due-to-sterility. Based on FDA recall #D-1508-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1508-2016%22&limit=1).
Why it’s dangerous
The primary hazard is the lack of assurance of sterility due to unsubstantiated validation of beyond-use dating. If the IV bag is not sterile, it can introduce bacteria or other contaminants directly into the bloodstream during intravenous administration, potentially causing serious infections or sepsis.
Who’s affected
Patients in Minnesota who received these specific compounded IV bags from The Apothecary are affected. Healthcare providers and patients using this medication for conditions requiring calcium, papaverine, phentolamine, or prostaglandin are at risk of exposure to non-sterile product.
How to tell if you have this one
Look for Calcium Gluconate 1% -- 1000 mL VIAFLEX IV bags labeled as Rx only. The product was manufactured by The Apothecary, a compounding pharmacy located at 165 19th St S #102, Sartell, MN 56377. Affected lots include those containing Calcium Gluconate, Papaverine, Phentolamine, and/or Prostaglandin, with specific lot numbers such as 12201604@21.
- Brand
The Apothecary- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
MN
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1508-2016 | Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377; LOT #: 12201604@21 | 40,000 mL |
| D-1509-2016 | Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377; LOT #: 12201604@22 | 840 mL |
| D-1510-2016 | Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377; LOT #: 06201604@15, 19201602@3, 06201604@8 | 450 mL |
| D-1511-2016 | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377; LOT #: 06201604@15, 19201602@3, 06201604@8 | 600 mL |
| D-1512-2016 | Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377; LOT #: 06201604@15, 19201602@3, 06201604@8 | 10 mL |
What to do — step by step
Stop Using the Product
Do not use any unexpired lots of the recalled Calcium Gluconate IV bags due to sterility concerns.
Contact Healthcare Provider
Consult your doctor or pharmacist immediately if you have used or currently possess the affected product to determine next steps for treatment.
Where it went and when
Where it was distributed
Distributed in Minnesota.
FDA distribution: “MN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Minnesota.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1508-2016 (June 20, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1508-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.