CLASS II Drug recall · Reported 28 Sep 2016 · FDA Enforcement Report
Calcium Gluconate 1% -- Viaflex IV recalled by W & C
W & C is recalling Calcium Gluconate 1% -- Viaflex IV, distributed in Minnesota. The recall was initiated on 20 Jun 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1508-2016
- FDA event ID
- 74606
- Recalling firm
- W & C, Sartell, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jun 2016
- FDA classified
- 16 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Jun 2016 | Recall initiated by company | |
| 16 Sep 2016 | Classified by FDA | +88 days |
| 28 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Where it was distributed
MN
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
LOT #: 12201604@21
Where was it sold?
MN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 74606| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Calcium Gluconate 2.5% -- Plastic Syringe recalled by W & C | W & C | Sterility | MN | |
| CLASS II | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin recalled by W & C | W & C | Sterility | MN | |
| CLASS II | Papaverine 30 mg / Phentolamine 1 mg / mL -- Glass Vial recalled | W & C | Sterility | MN | |
| CLASS II | Prostaglandin 200 mcg/ -- Glass Vial recalled by W & C | W & C | Sterility | MN |
More recalls from W & C
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prostaglandin 200 mcg/ -- Glass Vial recalled by W & C | W & C | Sterility | MN |
| Drug | CLASS II | Papaverine 30 mg / Phentolamine 1 mg / mL -- Glass Vial recalled | W & C | Sterility | MN |
| Drug | CLASS II | Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin recalled by W & C | W & C | Sterility | MN |
| Drug | CLASS II | Calcium Gluconate 2.5% -- Plastic Syringe recalled by W & C | W & C | Sterility | MN |