Agency classClass IIOur severity:Severe FDA (Drugs)·D-1508-2016·Announced 2016-09-28

The Apothecary Recalls Calcium Gluconate IV Bags Due to Sterility Concerns

The Apothecary is recalling Calcium Gluconate IV bags because the pharmacy could not verify that the products remained sterile for their labeled duration.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an IV medication is a significant risk that aligns with the Severe criteria for Class II recalls where the hazard is not merely theoretical but involves a failure of critical quality controls (sterility).

Plain-English summary

The Apothecary, a compounding pharmacy in Sartell, Minnesota, is recalling Calcium Gluconate 1% IV bags. The recall covers 40,000 mL of the medication, specifically lot number 12201604@21. The product is prescription-only and was distributed within Minnesota.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that the validation for the 'beyond use dating' of the medication was unsubstantiated. This means the pharmacy could not verify that the product remained sterile for the duration stated on the label. The notice also references other medications containing Calcium Gluconate, Papaverine, Phentolamine, and/or Prostaglandin, but the specific product identified in the structured data is the Calcium Gluconate 1% IV bag.

Patients who have received this medication should contact their healthcare provider for guidance. The FDA classifies this as a Class II recall, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
Manufacturer: W & C dba The Apothecary
Category: Drug — IV Medication
Hazard: sterility
infection

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 #: 12201604@21

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 5 recalled by W & C dba The Apothecary 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 5 products in this recall →

Same manufacturer · W & C dba The Apothecary

See all →

Severe
The Apothecary Recalls Sterile Injection Medications Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-09-28
Severe
Calcium Gluconate Syringes Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-09-28
Severe
The Apothecary Recalls Sterile Medications Due to Sterility Assurance Issues
FDA (Drugs) · 2016-09-28
Severe
The Apothecary Recalls Prostaglandin and Other Medications Due to Sterility Concerns
FDA (Drugs) · 2016-09-28

Same hazard · sterility