Wells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling specific lots of Trimix with Atropine Injectable because the agency could not ensure the product was sterile.
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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling specific lots of Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL. The recall affects 2 mL, 5 mL, and 10 mL vials compounded by Wells Pharmacy in Ocala, Florida. The product was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The affected lots were prepared between February 22, 2016, and September 14, 2016, and are within their expiration dates. Specific lot codes identified in the recall include 04042016@22, 07192016@3, and 04112016@13.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
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 (1)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
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 Tirzepatide 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 Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereTri-Mix Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereTri-Mix Injectable Recalled for Potential Sterility Issues
FDA (Drugs) · 2015-09-23
- SevereTri-Mix AT-1 Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereTri-Mix Injectable Recalled for Potential Sterility Assurance Issues
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls Tri-Mix Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereTri-Mix Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23