The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0146-2019·Announced 2018-11-07

Pharm D Solutions Recalls Calcium Gluconate Eyewash Due to Sterility Concerns

Pharm D Solutions is recalling 25 bottles of Calcium Gluconate 1% Eyewash Ophthalmic Solution because the company cannot ensure 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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a sterile medical product where sterility assurance is lacking is classified as Severe (Score 4) due to the potential for significant injury from contamination.

Plain-English summary

Pharm D Solutions, LLC is voluntarily recalling 25 bottles of Calcium Gluconate 1% Eyewash Ophthalmic Solution, 10 mg/mL, 1000 mL bottles (NDC 69699-0907-10). The recall was initiated because the company lacks assurance of the product's sterility.

The affected product was distributed nationwide. The specific lots involved are 05072018:27 (Discard by 5/2/2019) and 07122018:11 (Discard by 7/7/2019).

Consumers and healthcare providers should stop using the recalled product and contact Pharm D Solutions, LLC for further instructions or a refund.

The recalled product

Product
Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Ophthalmic Solution
Hazard
Affected units
25

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 (2)

  • Lots: 05072018:27 Discard by: 5/2/2019
  • 07122018:11 Discard by 7/7/2019

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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