Wells Pharmacy Recalls Injectable Glutamine/Arginine/Carnitine Vials Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 137 vials of compounded Glutamine/Arginine/Carnitine Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric for significant injury/property-damage reports or high-risk scenarios.
Plain-English summary
Wells Pharmacy Network LLC is recalling 137 vials of Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial. 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. Known lot codes include 07012016@10, 08032016@42, and 08182016@11.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 137
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 (4)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 07012016@10
- 08032016@42
- 08182016@11.
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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