Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 199 vials of a compounded injectable product nationwide due to a lack of assurance of 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious health consequences.
Plain-English summary
Wells Pharmacy Network LLC is recalling 199 vials of Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/mL, 30 mL vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The affected units include 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 06292016@9, 07252016@39, and 08102016@24.
The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 199
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: 06292016@9
- 07252016@39
- 08102016@24.
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.
See all 97 products in this recall →Related recalls
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