Pharm D Solutions Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
Pharm D Solutions is recalling 50 mL bags of 0.9% Sodium Chloride for Injection 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 severity score under the rubric for significant injury or property-damage reports or high-risk scenarios.
Plain-English summary
Pharm D Solutions, LLC is recalling 50 mL bags of 0.9% Sodium Chloride for Injection (NDC 69699-1426-10). The recall is being conducted because the company lacks assurance that the product is sterile.
The affected product consists of 12 bags per case. The specific lot number is 04192018:13, and the discard-by date is 10/16/2018. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a refund.
The recalled product
- Product
- 0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, Texas --- NDC 69699-1426-10
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 12
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 (1)
- Lot: 04192018:13 Discard by: 10/16/2018
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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