Well Care Compounding Pharmacy Recalls Levocarnitine Vials Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling levocarnitine 100mg/mL vials because FDA inspections found GMP violations that may affect sterility.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the 'Severe' criteria for significant potential harm.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Levocarnitine 100mg/mL packaged in 5mL vials. The product is prescription-only and was distributed in Nevada. The recall involves specific lots with expiration dates in April and May 2016.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, meaning there is a lack of assurance that the medication is sterile.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 869
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 (6)
- Lot #: 03142016:25@14
- Exp. 04/15/2016
- Lot #: 04182016: 22@14
- Exp. 05/18/2016
- Lot #: 04182016: 67@16
- Exp. 05/19/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy 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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