Well Care Compounding Pharmacy Recalls TRI-MIX # 2 Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling TRI-MIX # 2 vials because FDA inspections found violations that may affect sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (lack of sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of TRI-MIX # 2, a prescription-only medication packaged in 5mL vials. The product was distributed in Nevada.
The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The specific lot number is 11162016:19@6, with an expiration date of 02/15/2016.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Prescription
- 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 (2)
- Lot #: 11162016:19@6
- Exp.02/15/2016.
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 →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29