Pharm D Solutions Recalls Phosphate Buffer Solution Due to Sterility Concerns
Pharm D Solutions is recalling specific lots of Phosphate Buffer Solution 0.05 m Aqueous Solution because the company cannot assure 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, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.
Plain-English summary
Pharm D Solutions, LLC is recalling 1,900-milliliter bottles of Phosphate Buffer Solution 0.05 m Aqueous Solution (NDC 69699-0912-20). The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product was distributed nationwide. The recall covers two specific lots: Lot 06252018:63 with a discard-by date of 12/22/2018, and Lot 07312018:35 with a discard-by date of 1/26/2019.
Consumers and healthcare providers should check their inventory for these specific lot numbers and discard-by dates. If the product matches the recalled lots, it should be returned to the distributor or the recalling firm, Pharm D Solutions, LLC.
The recalled product
- Product
- Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-0912-20
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Pharmaceutical Solution
- Hazard
- Affected units
- 1,900
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)
- Lot: 06252018:63 Discard by: 12/22/2018
- 07312018:35 Discard by: 1/26/2019
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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