Wells Pharmacy Recalls Arginine HCl Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 351 vials of Arginine HCl 100 mg/mL 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug poses a significant risk of serious harm, aligning with the Severe criteria for Class II recalls with potential for significant injury.
Plain-English summary
Wells Pharmacy Network LLC is recalling 351 vials of Arginine HCl 100 mg/mL Injectable, 10 mL. The recall was initiated because of a lack of assurance of sterility. The affected product was compounded by Wells Pharmacy Network, LLC, in Ocala, Florida.
The recall covers all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 05122016@3, 07072016@15, and 08302016@65. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Affected units
- 351
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: 05122016@3
- 07072016@15
- 08302016@65
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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