Pharm D Solutions Recalls Levocarnitine Injectable Due to Sterility Concerns
Pharm D Solutions is recalling Levocarnitine 170 mg/mL Injectable because the product lacks assurance of sterility. The recall covers 3,000 milliliters distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Pharm D Solutions, LLC is recalling Levocarnitine 170 mg/mL Injectable (NDC 69699-1617-10) due to a lack of assurance of sterility. The recalled product consists of 3,000 milliliters of the injectable solution.
The affected lot is 04232018:63, with a discard-by date of 10/20/2018. The product was distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions or their healthcare provider for further instructions. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-10
- Manufacturer
- Pharm D Solutions, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 3,000
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: 04232018:63 Discard by: 10/20/2018
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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