Well Care Compounding Pharmacy Recalls TRI-MIX # 3 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling TRI-MIX # 3 vials because FDA inspections found GMP violations that may affect 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential sterility issues in injectable products.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of TRI-MIX # 3, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada. The recall involves two specific lots: Lot # 02162016:54@17 (Exp. 05/17/2016) and Lot # 03232016: 19@8 (Exp. 06/20/2016).
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. There is a lack of assurance that the recalled items are sterile.
Consumers and healthcare providers who have TRI-MIX # 3 from Well Care Compounding Pharmacy should stop using the product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 869
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)
- Lot #: 02162016:54@17
- Exp. 05/17/2016
- Lot #: 03232016: 19@8
- Exp. 06/20/2016.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy 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 51 products in this recall →Related recalls
Same manufacturer · Well Care Compounding Pharmacy
See all →- SeverePhosphatidylcholine/Deoxycholic Acid Injection Recalled for Sterility Concerns
FDA (Drugs) · 2016-06-15
- HighFDA Recalls Itraconazole Nasal Spray Due to Sterility Concerns
FDA (Drugs) · 2016-06-15
- ModerateWell Care Compounding Pharmacy Recalls Methylcobalamin Vials for Sterility Concerns
FDA (Drugs) · 2016-06-15
- HighWell Care Compounding Pharmacy Recalls Sterility-Compromised Glutathione Vials
FDA (Drugs) · 2016-06-15
- SevereGentamicin Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2016-06-15
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
- SevereFDA Recalls Tri-Mix Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereTri-Mix Injectable Recalled for Potential Sterility and Quality Issues
FDA (Drugs) · 2015-09-23
- SevereTri-Mix Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereCompounded Tri-Mix Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereTri-Mix Injectable Recalled for Potential Sterility Issues
FDA (Drugs) · 2015-09-23
- SevereTri-Mix Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23