Wells Pharmacy Recalls Carnitine-L Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 44 vials of Carnitine-L 250 mg/mL Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
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 agency classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the snippet, the 'lack of assurance of sterility' in an injectable drug represents a significant risk of serious harm (sepsis, infection), fitting the Severe category for Class II drug recalls where sterility is compromised.
Plain-English summary
Wells Pharmacy Network LLC is recalling 44 vials of Carnitine-L 250 mg/mL Injectable, 30 mL vials, which are prescription-only. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.
The recall includes all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Specific known lot codes include 07222016@2 and 08172016@1.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Affected units
- 44
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 (3)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 07222016@2
- 08172016@1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 97 recalled by Wells Pharmacy Network 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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