The Recall Desk
ModerateFDA (Drugs)·D-0149-2019·Announced 2018-11-07

Pharm D Solutions Recalls Calcium Gluconate Due to Sterility Concerns

Pharm D Solutions is recalling specific lots of Calcium Gluconate 2.5% products due to a lack of assurance of sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and no specific illnesses or injuries are reported in the source text.

Plain-English summary

Pharm D Solutions, LLC is recalling specific lots of Calcium Gluconate 2.5% products, including 250 mL bottles, nasal sprays, nebulization solutions, and oral sprays. The recall is being conducted due to a lack of assurance of sterility in the affected products.

The affected products include NDC 69699-0908-25, NDC 69699-0908-10, and NDC 69699-0917-60. The total quantity involved is 57 bottles, or 2,300 milliliters. The products were distributed nationwide.

Consumers and healthcare providers should check their inventory for the specific lot numbers and discard-by dates listed in the recall notice. If the products are found, they should be removed from use and returned to the distributor or disposed of according to local regulations.

The recalled product

Product
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-6
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Sterile Solutions
Hazard

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 (5)

  • Lots: a) 05072018:40 Discard by: 5/2/2019
  • b) 07262018:44 Discard by: 1/22/2019
  • c) 07122018:83 Discard by: 7/12/2019
  • d) 07262018:93 Discard by: 1/22/2019
  • e) 07262018:81 Discard by: 1/21/2019

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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Same hazard · sterility

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