Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 147 vials of a compounded injectable drug due to a lack of assurance of sterility. The products were 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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or injury.
Plain-English summary
Wells Pharmacy Network LLC is recalling 147 vials of a compounded injectable drug containing Glutamine, ORNI, Arginine, LYS, CITRU, and LIDO. The product is a 30 mL vial prepared by Wells Pharmacy in Ocala, Florida. The recall was initiated because of a lack of assurance of sterility.
The affected products include all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Specific known lot codes include 06232016@14, 07212016@2, 08012016@35, and 08192016@11. The agency has classified this recall as Class II.
The products were distributed nationwide. Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 147
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 (5)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known lot code: 06232016@14
- 07212016@2
- 08012016@35
- 08192016@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.
See all 97 products in this recall →Related recalls
Same manufacturer · Wells Pharmacy Network LLC
See all →- SevereWells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Compounded Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereWells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SeverePromise Pharmacy Recalls Amino Blend Injection Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- HighFDA Recalls Amino Blend Injectable Vials Due to Sterility Concerns
FDA (Drugs) · 2022-06-01
- HighCompounded Injectable Amino Acid Drug Recalled for Sterility Assurance Issues
FDA (Drugs) · 2022-07-20
- SevereInjectable Diet Aid Product Recalled for Sterility Assurance Failure
FDA (Drugs) · 2021-11-17
- SevereFDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- SeverePromise Pharmacy Recalls Leucine/Isoleucine/Valine Injection Due to Sterility Concerns
FDA (Drugs) · 2019-02-20