The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0147-2019·Announced 2018-11-07

Pharm D Solutions Recalls Calcium Gluconate Eyewash Due to Sterility Concerns

Pharm D Solutions is recalling 29 bottles of Calcium Gluconate 1% Eyewash 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, which corresponds to a Severe rating under the rubric for significant potential health risks.

Plain-English summary

Pharm D Solutions, LLC is recalling 29 bottles of Calcium Gluconate 1% Eyewash, 10 mg/mL, 125 mL bottles (NDC 69699-0906-12). 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 05072018:46 (discard by 5/1/2019) and 07122018:30 (discard by 7/7/2019).

Consumers who have this product should stop using it and contact Pharm D Solutions for further instructions or a refund.

The recalled product

Product
Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12
Manufacturer
Pharm D Solutions, LLC
Category
Drug — Ophthalmic
Hazard
Affected units
29

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: 05072018:46 Discard by: 5/1/2019
  • 07122018:30 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 →

Related recalls

Same manufacturer · Pharm D Solutions, LLC

See all →

Same hazard · sterility

See all →

Similar recalls