The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0148-2019·Announced 2018-11-07

Pharm D Solutions Recalls Calcium Gluconate Injectable Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of Calcium Gluconate 10% Injectable because the company cannot guarantee the product is sterile.

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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While the specific injury reports are not detailed in the text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of adverse health consequences, aligning with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

Pharm D Solutions, LLC is recalling 6,850 milliliters of Calcium Gluconate 10%, 100 mg/mL Injectable (NDC 69699-0914-30). The recall was initiated because the company lacks assurance of the product's sterility.

The affected lots are 07312018:46 (Discard by 1/27/2019), 07262018:97 (Discard by 1/21/2019), and 07122018:40 (Discard by 1/8/2019). The product was distributed nationwide.

Healthcare providers and patients should check their inventory for these specific lot numbers and discontinue use of the affected product. The U.S. Food and Drug Administration has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Injectable
Hazard
Affected units
6,850

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 (3)

  • Lots: 07312018:46 Discard by: 1/27/2019
  • 07262018:97 Discard by: 1/21/2019
  • 07122018:40 Discard by: 1/8/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, 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 79 products in this recall →

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