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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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