Pharm D Solutions Recalls Sterile Water Bags Due to Sterility Concerns
Pharm D Solutions is recalling 10 bags of Sterile Water 50 mL Aqueous Solution because the company cannot guarantee the product's sterility.
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 with potential for adverse health consequences (such as lack of sterility in an injectable solution) corresponds to a severity score of 4 (Severe), as it is not Class I but involves significant risk.
Plain-English summary
Pharm D Solutions, LLC is recalling 10 bags of Sterile Water 50 mL Aqueous Solution (NDC 69699-1421-50). The recall was initiated because the company lacks assurance of the product's sterility.
The affected product is identified by Lot 08092018:38 and has a discard-by date of 2/5/2018. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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
- Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1421-50
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Sterile Water
- Hazard
- Affected units
- 10
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: 08092018:38 Discard by: 2/5/2018
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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