Well Care Compounding Pharmacy Recalls M.l.C. Vials Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling M.l.C. 25mg/50mg/25mg/mL 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 3/5 (High).
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 involves a risk-of-harm product (sterility issues) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of M.l.C. 25mg/50mg/25mg/mL, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The source text does not report any specific illnesses or injuries associated with the product.
Patients who have received this medication should contact their healthcare provider for guidance on whether to discontinue use or seek a replacement.
The recalled product
- Product
- M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Compounded Medication
- 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 (20)
- Lot #: 01042016: 45@46
- Exp. 07/02/2016
- Lot #:01112016: 87@46
- Exp. 07/10/2016
- Lot #:01112016:78@63
- Exp. 07/10/2016
- Lot #: 01272016:81@30
- Exp.07/25/2016
- Lot #: 02102016:89@2
- Exp. 08/08/2016
- 02162016:25@57
- Exp.08/14/2016
- 02262016:33@54
- Exp.08/24/2016
- Lot #: 03092016:64@51
- Exp.09/07/2016
- Lot #: 04142016:01@45
- Exp.10/11/2016 04142016:17@37
- Exp.10/15/2016
- 04282016:72@48
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
- SevereCollagenase Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereHCG Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereHCG Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls HCG Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- HighMIC Compounded Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- SevereHCG Injection Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2015-09-23